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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01209949
First received: September 24, 2010
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel 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

  Eligibility

Ages Eligible for Study:   16 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209949

Locations
United States, Texas
Thomas J. Stephens and Associates
Carrollton, Texas, United States, 75006
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01209949     History of Changes
Other Study ID Numbers: US10179
Study First Received: September 24, 2010
Results First Received: December 13, 2011
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014