Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rosacea | Drug: Oxymetazoline Hydrochloride Drug: Rhofade Cream, 1% Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1103 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double Blind, Parallel Group, Three Arm, Placebo Controlled, Multi-Site Therapeutic Equivalence Study With Clinical End-points Comparing Test Product "Oxymetazoline Hydrochloride Cream, 1%" to Reference Product "RHOFADETM Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea |
Actual Study Start Date : | April 15, 2019 |
Actual Primary Completion Date : | January 7, 2020 |
Actual Study Completion Date : | February 27, 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Oxymetazoline hydrochloride Cream, 1%
Oxymetazoline hydrochloride cream, 1%
|
Drug: Oxymetazoline Hydrochloride
Test Comparator
|
Active Comparator: RHOFADE Cream, 1%
RHOFADE Cream, 1%
|
Drug: Rhofade Cream, 1%
Reference Comparator
Other Name: Oxymetazoline hydrochloride
|
Placebo Comparator: Vehicle Cream
Vehicle cream
|
Drug: Placebo
Placebo Comparator
Other Name: Oxymetazoline hydrochloride
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |
Site 1 | |
Lynchburg, Virginia, United States, 24501 |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 10, 2019 | ||||||
First Posted Date ICMJE | May 17, 2019 | ||||||
Last Update Posted Date | April 8, 2020 | ||||||
Actual Study Start Date ICMJE | April 15, 2019 | ||||||
Actual Primary Completion Date | January 7, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream" | ||||||
Official Title ICMJE | A Randomized, Double Blind, Parallel Group, Three Arm, Placebo Controlled, Multi-Site Therapeutic Equivalence Study With Clinical End-points Comparing Test Product "Oxymetazoline Hydrochloride Cream, 1%" to Reference Product "RHOFADETM Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea | ||||||
Brief Summary | A Randomized, Double-blind, Parallel-group, Three-arm, Placebo-controlled, Multi-Site Therapeutic Equivalence Study with Clinical End-points Comparing Test Product "Oxymetazoline hydrochloride Cream, 1%" to Reference Product "RHOFADE™ Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Rosacea | ||||||
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 |
1103 | ||||||
Original Estimated Enrollment ICMJE |
1233 | ||||||
Actual Study Completion Date ICMJE | February 27, 2020 | ||||||
Actual Primary Completion Date | January 7, 2020 (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 and older (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 | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03954444 | ||||||
Other Study ID Numbers ICMJE | OXY2018-01 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Actavis Inc. | ||||||
Study Sponsor ICMJE | Actavis Inc. | ||||||
Collaborators ICMJE | Teva Pharmaceuticals USA | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Actavis Inc. | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |