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Recruitment Status : Withdrawn (Market reasons)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

Tracking Information
First Submitted Date  ICMJE March 30, 2020
First Posted Date  ICMJE April 1, 2020
Last Update Posted Date June 26, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • Mean percent change from baseline in the inflammatory lesion count. [ Time Frame: 12 weeks ]
    Mean percent reduction compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population.
  • Mean percent change from baseline in the non-inflammatory lesion count. [ Time Frame: 12 weeks ]
    Mean percent reduction compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
  • 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.
  • Reduction 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%
Official Title  ICMJE 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
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Adapalene 0.1% Gel
    A thin film of the assigned medication to be applied once daily in the evening 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
  • Other: Placebo
    A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
Study Arms  ICMJE
  • Experimental: Test Group
    Adapalene Gel, 0.1%, applied as thin film once daily for 12 weeks
    Intervention: Drug: Adapalene 0.1% Gel
  • Active Comparator: Reference Group
    Differin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks
    Intervention: Drug: Differin 0.1% Topical Gel
  • Placebo Comparator: Placebo Group
    Placebo Gel, 0.1%, applied as thin film once daily for 12 weeks
    Intervention: Other: Placebo
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 24, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2020)
980
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04329403
Other Study ID Numbers  ICMJE CR191-18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aurobindo Pharma Ltd
Study Sponsor  ICMJE Aurobindo Pharma Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aurobindo Pharma Ltd
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP