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CompletedNCT04321070Updated Apr 10, 2025

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

A Phase 1 interventional study of Clindamycin Phosphate and Clindamycin Phosphate RLD in Acne Vulgaris, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-04-10.

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

Phase
Phase 1
Study type
Interventional
Enrollment
550
Allocation
Randomized
Ages
12 Years to 40 Years
Sex
All
01

Study summary

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Read the detailed description

Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both 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
No

Inclusion criteria

  • Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
  • Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
  • Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion criteria

Exclusion Criteria:

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
  • Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
550 participants (actual)

Study arms

  • Experimental
    Clindamycin Phosphate

    Topical, once daily, for 84 days.

    Drug: Clindamycin Phosphate

  • Active comparator
    Clindamycin Phosphate RLD

    Topical, once daily, for 84 days

    Drug: Clindamycin Phosphate RLD

  • Placebo comparator
    Vehicle of the test product

    Topical, once daily, for 84 days

    Drug: Placebos

Interventions

  • DrugClindamycin Phosphate

    A thin film of investigation product will be applied to the affected areas of the face once daily

    Also known as: Lotion

  • DrugClindamycin Phosphate RLD

    A thin film of investigation product will be applied to the affected areas of the face once daily

    Also known as: Lotion

  • DrugPlacebos

    A thin film of investigation product will be applied to the affected areas of the face once daily

    Also known as: Vehicle

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: Week 12

06

Study locations

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

Registry details

Key details

Study ID
NCT04321070
Lead sponsor
Taro Pharmaceuticals USA
Responsible party
Sponsor
First posted
Mar 25, 2020
Start date
Sep 9, 2019
Primary completion
Dec 14, 2019
Completion
Mar 6, 2020
Last update
Apr 10, 2025

Study contacts

Natalie Yantovskiy
study director · Taro Pharmaceuticals, Inc.

Oversight

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

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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