Condition or disease | Intervention/treatment | Phase |
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Skin Care | Other: Serum Other: Lotion Other: Cream Other: Normal Saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | A Photo-irritation and Photo-sensitisation Study in Healthy Subjects for Three Developmental Cosmetic Facial Products |
Actual Study Start Date : | August 28, 2019 |
Actual Primary Completion Date : | October 11, 2019 |
Actual Study Completion Date : | October 11, 2019 |
Arm | Intervention/treatment |
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Experimental: Developmental Serum
All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing developmental serum (0.02milliliters per centimeter square[mL/cm^2] in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental serum will be re-applied and 1 of the 2 sites will be irradiated with 2.5 Joules per centimeters square(J/cm^2) ultraviolet(UV) A radiation,then with 0.3 minimal erythemal doses(MEDs) of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation
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Other: Serum
Participants will be topically applied adhesive patch containing developmental serum
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Experimental: Developmental Lotion
All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing developmental lotion (0.02mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental lotion will be re-applied and 1 of the 2 sites will be irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation
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Other: Lotion
Participants will be topically applied adhesive patch containing developmental lotion
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Experimental: Developmental Cream
All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing developmental cream (0.02mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, developmental cream will be re-applied and 1 of the 2 sites will be irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation
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Other: Cream
Participants will be topically applied adhesive patch containing developmental cream
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Placebo Comparator: Negative Control
All participants in induction phase will be topically applied 2 semi-occlusive patch (Monday) containing 0.9 percent normal saline (0.02mL/cm^2 in an individual cell of patch) at 2 sites on the dorsum for 24 hours, post patch removal(Tuesday), sites will be cleaned, normal saline will be re-applied and 1 of the 2 sites will be irradiated with 2.5J/cm^2 UVA radiation, then with 0.3 MEDs of UVA+UVB radiation. 24 hours post irradiation (Wednesday), sites will be assessed and duplicate patches applied as on Monday for 24 hours. Irradiation on Thursday similar to Tuesday and assessment post 24 hour irradiation on Friday. Same process repeated for 3 weeks. In challenge phase all participants will be applied 2 semi-occlusive patches at 2 naive sites for 24 hours, post which 1 site will be irradiated (same as induction phase). Assessment will be after 24, 48 and 72 hours of irradiation
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Other: Normal Saline
Participants will be topically applied adhesive patch containing normal saline
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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 |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
GSK Investigational Site | |
Campinas, São Paulo, Brazil, 13084-791 |
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 | |||||||||||||||||||
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First Submitted Date ICMJE | July 1, 2019 | ||||||||||||||||||
First Posted Date ICMJE | July 5, 2019 | ||||||||||||||||||
Results First Submitted Date ICMJE | October 7, 2020 | ||||||||||||||||||
Results First Posted Date ICMJE | November 2, 2020 | ||||||||||||||||||
Last Update Posted Date | December 17, 2020 | ||||||||||||||||||
Actual Study Start Date ICMJE | August 28, 2019 | ||||||||||||||||||
Actual Primary Completion Date | October 11, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With Photo-initiated Potential Sensitization Reaction [ Time Frame: Day 40 ] Scoring of patch test reactions was performed by blind evaluator as per International Contact Dermatitis Research Group (ICDRG) grading '- 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,vesicles); '+++':extreme positive reaction (bullous reaction, intense erythema and infiltration, coalescing vesicles).Score range '- to +++' where '-' indicated no adverse reaction and '+++' indicated very strong adverse reaction.Any positive reaction ('+' or greater):considered potential sensitization(PS) upon dermatologist discretion and as potential photo-initiated if a)positive reaction occur at ultraviolet (UV) exposed site,b)occur at both UV and non-UV sites with maximum score at UV exposed site being higher than non-UV exposed site.Percentage of participants with photo-initiated PS were reported in numbers.
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Original Primary Outcome Measures ICMJE |
Proportion of Participants With Photo-initiated Potential Sensitization Reaction [ Time Frame: Day 40 ] Scoring of patch test reactions will be performed by blind evaluator as per International Contact Dermatitis Research Group grading'- 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. Any positive reaction (a score of '+' or greater): considered potential sensitization(PS) based upon dermatologist discretion and will further be classified as potential photo-initiated if a) a positive reaction occur only at ultraviolet (UV) exposed site, or b)occur at both sites(UV and non-UV) with the maximum score at the UV exposed site being higher than the maximum score at the non-UV exposed site. Proportion of participants with photo-initiated PS will be reported in this outcome measure.
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Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion | ||||||||||||||||||
Official Title ICMJE | A Photo-irritation and Photo-sensitisation Study in Healthy Subjects for Three Developmental Cosmetic Facial Products | ||||||||||||||||||
Brief Summary | The purpose of this study is to demonstrate the absence of sensitisation and irritation potential of a product when applied to the skin and exposed to ultraviolet (UV) radiation. Photo-sensitisation potential will primarily be evaluated through a subsequent semi-occluded application and UV exposure (challenge phase) after a 2-week rest period. Photo-irritation potential will primarily be evaluated through the repeated occluded application and UV exposure of the study products over 3 weeks (induction phase). | ||||||||||||||||||
Detailed Description | A single-center, randomised, evaluator (single) blind study in healthy adult participants aged 18 to 65 years with no dermatological disorders to evaluate the cutaneous photo- irritation and photo-sensitisation potential of three cosmetic facial skincare products. During Screening (Visit 1), the participants will sign an informed consent, will undergo dermatological assessment to ensure they have no dermatoses on their dorsum that might impact their safety, Fitzpatrick Phototype of II to IV and colorimetry analysis of their skin type using the Individual Typology Angle, which will be used to estimate minimal erythemal dose (MED). At Visit 2, the eligible participants will undergo MED irradiation where the participant will be administered a series of 6 controlled doses of UV radiation. At Visit 3, the participants will undergo MED determination, where a trained evaluator will evaluate the exposed skin to determine the lowest dose of UV radiation required to induce uniform, unambiguous erythema for signs of visible erythema. Further, the study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase (3 weeks: Visit 4 to Visit 18); at visit 4, the area for applying 2 consecutive patches will be designated between the scapula and waistline. A controlled amount (0.02 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). Every Monday, patch sites will be evaluated, 2 patches will be applied, post 24 hours (Tuesday) the patches will be removed, patch sites can be cleaned, patch sites will be evaluated, test products/ saline will be re-applied and 1 of the 2 sites will be irradiated with 2.5 Joules per centimetre square UVA radiation with a Schott UG11+WG335 filter (or equivalent) in place, and then with 0.3 MEDs of UVA+UVB radiation (filters UG11+WG320). The sites will be assessed immediately after irradiation and 24 hours post irradiation (Wednesday) and duplicate patches will be re-applied as applied on Monday. Same procedure will be repeated on Thursday as done on Tuesday and on Friday the patch sites will be evaluated. The same process will continue for 3 consecutive weeks. Then there will be 2 weeks of Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 19 to Visit 23) where there will be a duplicate parallel series of product applications under semi-occlusive patches to 2 naïve areas on Monday. Post 24 hours (Tuesday) patches will be removed and 1 of the 2 sites will be irradiated similar as done in induction phase. The sites will be assessed immediately post irradiation and after 24 hours (Tuesday), 48 hours (Wednesday) and 72 hours (Thursday) of irradiation. At visit 23, after the challenge phase the final assessments will be performed by the dermatologist. | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Other |
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Condition ICMJE | Skin Care | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
40 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
30 | ||||||||||||||||||
Actual Study Completion Date ICMJE | October 11, 2019 | ||||||||||||||||||
Actual Primary Completion Date | October 11, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | NCT04006795 | ||||||||||||||||||
Other Study ID Numbers ICMJE | 212378 | ||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | GlaxoSmithKline | ||||||||||||||||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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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 |