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CompletedNCT03427554Updated May 18, 2018

To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

An Early Phase 1 interventional study of Tretinoin cream 0.1% and RETIN-A® Cream in Acne Vulgaris, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 12 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Taro Pharmaceuticals USA · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
455
Allocation
Randomized
Ages
12 Years to 40 Years
Sex
All
01

Study summary

Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

Read the detailed description

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

02

Conditions studied

  • Acne Vulgaris

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03

Who can participate

Ages eligible
12 Years to 40 Years
Sexes eligible
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

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
455 participants (actual)

Study arms

  • Experimental
    Tretinoin cream 0.1%

    Once daily at home, to apply the entire affected areas of the face.

    Drug: Tretinoin cream 0.1%

  • Active comparator
    RETIN-A® Cream

    Once daily at home, to apply the entire affected areas of the face.

    Drug: RETIN-A® Cream

  • 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

Interventions

  • DrugTretinoin cream 0.1%

    Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

    Also known as: Tretinoin

  • DrugRETIN-A® Cream

    RETIN-A® (Tretinoin) Cream (Valeant)

    Also known as: Tretinoin

  • DrugVehicle of the test product

    Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

    Also known as: Placebo

05

What researchers measure

Primary outcomes

  1. Demonstration of Bioequivalence

    Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

    Time frame: 12 weeks

06

Study locations

1 site
  • Catawba Research, LLC
    Charlotte, North Carolina 28217, United States
07

Registry details

Key details

Study ID
NCT03427554
Lead sponsor
Taro Pharmaceuticals USA
Responsible party
Sponsor
First posted
Feb 9, 2018
Start date
Aug 21, 2017
Primary completion
Jan 26, 2018
Completion
Jan 26, 2018
Last update
May 18, 2018

Study contacts

Zaidoon A Al-Zubaidy
study director · Catawba Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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