Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04329403
Recruitment Status : Withdrawn (Market reasons)
First Posted : April 1, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Aurobindo Pharma Ltd

Brief Summary:
To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene 0.1% Gel Drug: Differin 0.1% Topical Gel Other: Placebo Phase 3

Detailed Description:
Bio-Equivalence study with a clinical endpoint in the treatment of acne vulgaris comparing adapalene cream, 0.1% test product versus the reference listed drug (RLD) and placebo (vehicle) control, each administered as one application once a day in the evening for 12 weeks

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene

Arm Intervention/treatment
Experimental: Test Group
Adapalene Gel, 0.1%, applied as thin film once daily for 12 weeks
Drug: Adapalene 0.1% Gel
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Active Comparator: Reference Group
Differin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks
Drug: Differin 0.1% Topical Gel
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Placebo Comparator: Placebo Group
Placebo Gel, 0.1%, applied as thin film once daily for 12 weeks
Other: Placebo
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks




Primary Outcome Measures :
  1. Mean percent change from baseline in the inflammatory lesion count. [ Time Frame: 12 weeks ]
    Mean percent change compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population.

  2. Mean percent change from baseline in the non-inflammatory lesion count. [ Time Frame: 12 weeks ]
    Mean percent change compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population.


Secondary Outcome Measures :
  1. Proportion of subjects with a clinical response as success or failure [ Time Frame: 12 weeks ]
    Success will be defined as IGA score that is at least 2 grades less than the baseline assessment. Failure is defined as an IGA score that is the same, higher or one grade lower than the baseline assessment.

  2. Change in lesion count [ Time Frame: 12 weeks ]
    Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
  2. On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts)
  3. Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4
  4. Willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period
  5. If female of childbearing potential, willing to use an acceptable form of birth control during the study

Exclusion Criteria:

  1. Pregnant, breast feeding or planning a pregnancy
  2. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis)
  3. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris
  4. History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients
  5. Use within 6 months prior to baseline or during the study of oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
  6. Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study
  7. Use on the face within 1 month prior to baseline or during the study of 1) cryo destruction or chemo destruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy
  8. Use within 1 month prior to baseline or during the study of 1) systemic steroids, 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 4) systemic anti-inflammatory agents
  9. Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics
Layout table for additonal information
Responsible Party: Aurobindo Pharma Ltd
ClinicalTrials.gov Identifier: NCT04329403    
Other Study ID Numbers: CR191-18
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents