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

Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

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: NCT01209949
Recruitment Status : Completed
First Posted : September 27, 2010
Results First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE September 24, 2010
First Posted Date  ICMJE September 27, 2010
Results First Submitted Date  ICMJE December 13, 2011
Results First Posted Date  ICMJE January 19, 2012
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE October 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 [ Time Frame: 12 weeks ]
Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Number of participants who were a Success (Investigator's Global Assessment of 'Clear' or 'Almost Clear') at week 12 [ Time Frame: 12 weeks ]
Number of participants who were a Success (Investigator's Global Assessment of 'Clear or 'Almost Clear') at week 12. Investigator's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
  • Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. [ Time Frame: Week 12 ]
    Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
  • Number of Participants With Tolerability Assessments Resulting in an Adverse Event [ Time Frame: 12 weeks ]
    Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
  • Percent change from baseline in lesion counts (inflammatory, non-inflammatory, and total) at each post-baseline visit [ Time Frame: Week 4, Week 8 and Week 12 ]
    Percent change (as mean) from baseline in lesions counts (inflammatory, non-inflammatory, and total) at each post-baseline visit (Week 4, Week 8 and Week 12).
  • Number of Participants With Tolerability Assessments Resulting in an Adverse Event [ Time Frame: 12 weeks ]
    Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Official Title  ICMJE Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Brief Summary The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Apply adapalene BPO gel once daily in the evening for 12 weeks
Other Name: Epiduo® Gel
Study Arms  ICMJE Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Intervention: Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects, aged 16 to 25 years inclusive;
  • Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
  • A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
  • Subjects who agree to be photographed at each visit;
  • Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Exclusion Criteria:

  • Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
  • Subjects with a wash-out period for topical acne treatment on the face less than 30 days
  • Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
  • Subjects who are currently being treated with antibiotics;
  • Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
  • Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 25 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01209949
Other Study ID Numbers  ICMJE US10179
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
PRS Account Galderma Laboratories, L.P.
Verification Date January 2012

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