To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris
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ClinicalTrials.gov Identifier: NCT03427554 |
Recruitment Status :
Completed
First Posted : February 9, 2018
Last Update Posted : May 18, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: Tretinoin cream 0.1% Drug: RETIN-A® Cream Drug: Vehicle of the test product | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 455 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris |
Actual Study Start Date : | August 21, 2017 |
Actual Primary Completion Date : | January 26, 2018 |
Actual Study Completion Date : | January 26, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Tretinoin cream 0.1%
Once daily at home, to apply the entire affected areas of the face.
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Drug: Tretinoin cream 0.1%
Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Other Name: Tretinoin |
Active Comparator: RETIN-A® Cream
Once daily at home, to apply the entire affected areas of the face.
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Drug: RETIN-A® Cream
RETIN-A® (Tretinoin) Cream (Valeant)
Other Name: Tretinoin |
Placebo Comparator: Vehicle of the test product
Once daily at home, to apply the entire affected areas of the face.
|
Drug: Vehicle of the test product
Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
Other Name: Placebo |
- Demonstration of Bioequivalence [ Time Frame: 12 weeks ]Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

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Ages Eligible for Study: | 12 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
- Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Exclusion Criteria:
- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427554
United States, North Carolina | |
Catawba Research, LLC | |
Charlotte, North Carolina, United States, 28217 |
Study Director: | Zaidoon A Al-Zubaidy | Catawba Research |
Responsible Party: | Taro Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT03427554 |
Other Study ID Numbers: |
TRTC 1622 |
First Posted: | February 9, 2018 Key Record Dates |
Last Update Posted: | May 18, 2018 |
Last Verified: | May 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |
Tretinoin Antineoplastic Agents Keratolytic Agents Dermatologic Agents |