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出境医 / 临床实验 / To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products

To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products

Study Description
Brief Summary:
The aim of this study is to assess irritant or allergic response of 3 developmental cosmetic facial products following a conventional human repeated insult patch test methodology for 6 weeks.

Condition or disease Intervention/treatment Phase
Skin Care Other: Serum Other: Lotion Other: Cream Other: Normal Saline Not Applicable

Detailed Description:
A randomized, single blind (evaluator), single-center, Human Repeat Insult Patch Test (HRIPT) study in healthy adult participants aged 18 to 65 years to evaluate the cutaneous irritation and contact sensitization potential of 3 cosmetic facial skincare products. The participants will undergo repeated cutaneous application of semi-occlusive patch of 3 cosmetic facial skincare products and a reference product as a negative control (saline solution). HRIPT is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions. Screening of the participants will be performed at Visit 1 (i.e. from Day 0 to Day 14). The study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase will continue for 3 consecutive weeks (Visit 2 to Visit 10); at visit 2, the area for patch application will be designated between the scapula and waistline, away from the spinal mid-line. A controlled amount (0.02 milliliters per centimeters square [mL/cm^2]) of each study product will be randomly assigned within the patch system of each participant into the appropriate separate cell (3 cells for each of the test products and 1 cell for the saline solution). Each patch will remain in place for 48 (± 4) hours on weekdays and 72 (± 4) hours on weekend. Induction phase will be followed by 2-week (Visit 11) Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 12 to Visit 15) in which a naïve area of the skin will be selected and a new patch with each of the cells filled with study products will be applied. After 48 (±4) hours of patch application, participants will return to the site, the patch will be removed, and subsequent test-site evaluations will be performed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The human repeated insult patch test (HRIPT) is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions.
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Human Repeat Insult Patch Test (HRIPT) in Healthy Subjects to Assess the Cutaneous Irritation and Sensitization Potential of Three Developmental Cosmetic Facial Products
Actual Study Start Date : August 30, 2019
Actual Primary Completion Date : November 29, 2019
Actual Study Completion Date : November 29, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Developmental Serum
The participants will be applied a semi-occlusive adhesive patch containing the developmental serum (0.02 milliliters per centimeters square [mL/cm^2] in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
 Other: Serum
Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square [mL/cm^2] of serum in an individual cell of patch)
Experimental: Developmental Lotion
The participants will be applied a semi-occlusive adhesive patch containing the developmental lotion (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
 Other: Lotion
Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of lotion in an individual cell of patch)
Experimental: Developmental Cream
The participants will be applied a semi-occlusive adhesive patch containing the developmental cream (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
 Other: Cream
Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of cream in an individual cell of patch)
Placebo Comparator: Negative Control
The participants will be applied a semi-occlusive adhesive patch containing the 0.9 percent (%) normal saline (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
 Other: Normal Saline
Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of normal saline in an individual cell of patch)
Outcome Measures
Primary Outcome Measures :
  1. Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40 [ Time Frame: Day 40 ]
    Human repeated insult patch test (HRIPT) reactions as per (ICDRG) were scored by trained blind evualuator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment of positive reactions was determined by the blinded dermatologist and reported as Yes/ No/ Unable to determine. Percentage of participants with potential sensitization (count of "Yes"/ total reactions) were reported in form of numbers in this outcome measure.


Secondary Outcome Measures :
  1. Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator [ Time Frame: Day 40 ]
    HRIPT reactions as per ICDRG were scored by trained blind evaluator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment was determined by the blinded dermatologist and reported as a score of '+' or greater. Percentage of participants with any positive reaction (a score of '+' or greater) will be reported in numbers in this outcome measure.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant provision of a signed and dated in-formed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • A participant who is willing and able to comply with scheduled visits, treatment plan, and study procedures.
  • A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, with no clinically significant or relevant abnormalities in medical history or upon dermal examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
  • A participant with Fitzpatrick phototype I to IV.
  • A participant with healthy, intact skin at the proposed test area dorsum (below the shoulder, above the waist), as evaluated by a dermatologist, to ensure participant is free of clinically relevant dermatological conditions.

Exclusion Criteria:

  • A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies involving investigational product(s) within 30 Days prior to study entry and/or during study participation.
  • A participant who has participated in other studies including non-medicinal, cosmetic studies within 7 Days prior to study entry and/or during study participation.
  • A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • A participant who is pregnant or intends to be-come pregnant during the study duration (self-reported).
  • A participant who is breastfeeding.
  • A participant with known or suspected intolerance or hypersensitivity to the study materials/product (or closely related com-pounds) or any of their stated ingredients, to hypoallergenic tape, or to the cotton patches.
  • A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
  • A participant unwilling or unable to comply with the Lifestyle Considerations; a) applying other product to test site, using cosmetics, b) changing dietary habits, c) getting patch test site wet, d) removing the patch, e) wearing tight or restrictive clothing that can remove patch, and f) engaging in activities that result in excessive sweating.
  • A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
  • A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
  • A participant with any history of significant diseases or medical conditions known to alter skin appearance or physiologic response (e.g. uncontrolled diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
  • A participant considered immune-compromised.
  • A participant with active dermatosis (local or disseminated) that might interfere with the results of the study.
  • A participant currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product or place the participant at undue risk.
  • A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS, high dose aspirin), and/or corticosteroids.
  • A participant who has used a transcutaneous electrical nerve stimulation (TENS) machine 1 day before the screening visit.
  • A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
  • A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study.
  • A participant with any skin marks on the back that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, open sores, pimples, cysts, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
  • A participant that intends bathing (in the sea or a pool), using sauna, or partaking in water sports, or activities that lead to intense sweating.
  • A participant that is a prisoner or involuntary incarcerated.
  • A participant from an indigenous tribe.
  • A participant who has previously been enrolled in this study.
Contacts and Locations

Locations
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Brazil
GSK Investigational Site
Campinas, São Paulo, Brazil, 13084-791
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Results First Submitted Date  ICMJE November 12, 2020
Results First Posted Date  ICMJE December 10, 2020
Last Update Posted Date December 10, 2020
Actual Study Start Date  ICMJE August 30, 2019
Actual Primary Completion Date November 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2020) 		Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40 [ Time Frame: Day 40 ]
Human repeated insult patch test (HRIPT) reactions as per (ICDRG) were scored by trained blind evualuator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment of positive reactions was determined by the blinded dermatologist and reported as Yes/ No/ Unable to determine. Percentage of participants with potential sensitization (count of "Yes"/ total reactions) were reported in form of numbers in this outcome measure.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		Percentage of Participants With Potential Sensitisation Reactions as Assessed by Dermatologist on Day 40 [ Time Frame: Day 40 ]
Scoring of human repeated insult patch test (HRIPT) reactions as per The International Contact Dermatitis Research Group (ICDRG) is '- to +++', where '-' negative reaction, '?+' doubtful reaction; faint erythema only, '+' weak (non-vesicular) positive reaction; erythema, infiltration and possibly papules, '++' strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles, '+++' extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles (higher the positive score, more will be the cutaneous irritation or allergic response). Scoring of the patch site will be performed by a trained blind evaluator. Any positive reaction (a score of '+' or greater) will be considered as potential sensitization based upon dermatologist discretion. Percentage of participants with potential sensitization will be reported in this outcome measure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2020) 		Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator [ Time Frame: Day 40 ]
HRIPT reactions as per ICDRG were scored by trained blind evaluator on the scale of '- to +++', where '-':negative reaction,'?+':doubtful reaction; faint erythema only,'+': weak (non-vesicular) positive reaction;erythema, infiltration and possibly papules,'++': strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles,'+++': extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles. Score '-' indicated no adverse reaction, whereas, '+++' indicated very strong adverse reaction. Any positive reaction (a score of '+' or greater) was considered as potential sensitization based upon dermatologist discretion. The assessment was determined by the blinded dermatologist and reported as a score of '+' or greater. Percentage of participants with any positive reaction (a score of '+' or greater) will be reported in numbers in this outcome measure.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		Percentage of Participants With a Positive Reaction Score (Score of '+' or Greater) as Assessed by a Trained Evaluator [ Time Frame: Day 40 ]
Scoring of HRIPT reactions as per ICDRG is '- to +++', where '-' negative reaction, '?+' doubtful reaction; faint erythema only, '+' weak (non-vesicular) positive reaction; erythema, infiltration and possibly papules, '++' strong (vesicular) positive reaction; erythema, infiltration, papules and vesicles, '+++' extreme positive reaction; bullous reaction, intense erythema and infiltration, coalescing vesicles (higher the positive score, more will be the cutaneous irritation or allergic response). Scoring of the patch site will be performed by a trained blind evaluator. Percentage of participants with any positive reaction (a score of '+' or greater) will be reported in this outcome measure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products
Official Title  ICMJE A Human Repeat Insult Patch Test (HRIPT) in Healthy Subjects to Assess the Cutaneous Irritation and Sensitization Potential of Three Developmental Cosmetic Facial Products
Brief Summary The aim of this study is to assess irritant or allergic response of 3 developmental cosmetic facial products following a conventional human repeated insult patch test methodology for 6 weeks.
Detailed Description A randomized, single blind (evaluator), single-center, Human Repeat Insult Patch Test (HRIPT) study in healthy adult participants aged 18 to 65 years to evaluate the cutaneous irritation and contact sensitization potential of 3 cosmetic facial skincare products. The participants will undergo repeated cutaneous application of semi-occlusive patch of 3 cosmetic facial skincare products and a reference product as a negative control (saline solution). HRIPT is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions. Screening of the participants will be performed at Visit 1 (i.e. from Day 0 to Day 14). The study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase will continue for 3 consecutive weeks (Visit 2 to Visit 10); at visit 2, the area for patch application will be designated between the scapula and waistline, away from the spinal mid-line. A controlled amount (0.02 milliliters per centimeters square [mL/cm^2]) of each study product will be randomly assigned within the patch system of each participant into the appropriate separate cell (3 cells for each of the test products and 1 cell for the saline solution). Each patch will remain in place for 48 (± 4) hours on weekdays and 72 (± 4) hours on weekend. Induction phase will be followed by 2-week (Visit 11) Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 12 to Visit 15) in which a naïve area of the skin will be selected and a new patch with each of the cells filled with study products will be applied. After 48 (±4) hours of patch application, participants will return to the site, the patch will be removed, and subsequent test-site evaluations will be performed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The human repeated insult patch test (HRIPT) is a long standing, standard method to determine whether exposure to a topical product will elicit a cutaneous (dermal) irritant or allergic response (sensitization) under exaggerated (occluded) conditions.
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Skin Care
Intervention  ICMJE
  • Other: Serum
    Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square [mL/cm^2] of serum in an individual cell of patch)
  • Other: Lotion
    Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of lotion in an individual cell of patch)
  • Other: Cream
    Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of cream in an individual cell of patch)
  • Other: Normal Saline
    Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of normal saline in an individual cell of patch)
Study Arms  ICMJE
  • Experimental: Developmental Serum
    The participants will be applied a semi-occlusive adhesive patch containing the developmental serum (0.02 milliliters per centimeters square [mL/cm^2] in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
    Intervention: Other: Serum
  • Experimental: Developmental Lotion
    The participants will be applied a semi-occlusive adhesive patch containing the developmental lotion (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
    Intervention: Other: Lotion
  • Experimental: Developmental Cream
    The participants will be applied a semi-occlusive adhesive patch containing the developmental cream (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
    Intervention: Other: Cream
  • Placebo Comparator: Negative Control
    The participants will be applied a semi-occlusive adhesive patch containing the 0.9 percent (%) normal saline (0.02 mL/cm^2 in an individual cell of the patch) topically to the dorsum, repeatedly for 3 weeks (9 times) in induction phase (48 hours in weekdays and 72 hours in weekends) and for 48 hours (single application) in the challenge phase.
    Intervention: Other: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2020) 		302
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		250
Actual Study Completion Date  ICMJE November 29, 2019
Actual Primary Completion Date November 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant provision of a signed and dated in-formed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • A participant who is willing and able to comply with scheduled visits, treatment plan, and study procedures.
  • A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, with no clinically significant or relevant abnormalities in medical history or upon dermal examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
  • A participant with Fitzpatrick phototype I to IV.
  • A participant with healthy, intact skin at the proposed test area dorsum (below the shoulder, above the waist), as evaluated by a dermatologist, to ensure participant is free of clinically relevant dermatological conditions.

Exclusion Criteria:

  • A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies involving investigational product(s) within 30 Days prior to study entry and/or during study participation.
  • A participant who has participated in other studies including non-medicinal, cosmetic studies within 7 Days prior to study entry and/or during study participation.
  • A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • A participant who is pregnant or intends to be-come pregnant during the study duration (self-reported).
  • A participant who is breastfeeding.
  • A participant with known or suspected intolerance or hypersensitivity to the study materials/product (or closely related com-pounds) or any of their stated ingredients, to hypoallergenic tape, or to the cotton patches.
  • A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
  • A participant unwilling or unable to comply with the Lifestyle Considerations; a) applying other product to test site, using cosmetics, b) changing dietary habits, c) getting patch test site wet, d) removing the patch, e) wearing tight or restrictive clothing that can remove patch, and f) engaging in activities that result in excessive sweating.
  • A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
  • A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
  • A participant with any history of significant diseases or medical conditions known to alter skin appearance or physiologic response (e.g. uncontrolled diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
  • A participant considered immune-compromised.
  • A participant with active dermatosis (local or disseminated) that might interfere with the results of the study.
  • A participant currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product or place the participant at undue risk.
  • A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS, high dose aspirin), and/or corticosteroids.
  • A participant who has used a transcutaneous electrical nerve stimulation (TENS) machine 1 day before the screening visit.
  • A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
  • A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study.
  • A participant with any skin marks on the back that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, open sores, pimples, cysts, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
  • A participant that intends bathing (in the sea or a pool), using sauna, or partaking in water sports, or activities that lead to intense sweating.
  • A participant that is a prisoner or involuntary incarcerated.
  • A participant from an indigenous tribe.
  • A participant who has previously been enrolled in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007159
Other Study ID Numbers  ICMJE 212383
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
PRS Account GlaxoSmithKline
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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