| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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 |
|
||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||
| 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 |
||||||
| 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. |
|||||||
| 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:
|
||||||
| Sex/Gender ICMJE |
|
||||||
| 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 |
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