Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face
An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products (Retin-A Micro Gel, 0.04% Pump and Epiduo Gel) Using a Split-Face Model
1 other identifier
interventional
162
1 country
1
Brief Summary
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
April 9, 2010
CompletedFebruary 15, 2012
February 1, 2012
3 months
August 4, 2009
January 26, 2010
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Facial Irritation and Cutaneous Effects
Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.
three weeks
Study Arms (1)
Tretinoin & Adapalene-Benzoyl Peroxide
EXPERIMENTALTretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Interventions
A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.
A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Before screening, subjects (or legally authorized representative) must read and sign the IRB approved Informed Consent Form (includes HIPPA and Photo release)
- Subjects must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator to have healthy skin
- Subject's bilateral facial skin must be clear of any confounding irritation, rashes, acne, rosacea, etc. prior to the study
- Subject must be free of systemic retinoids for at least 2 months
- Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide or systemic steroids for 1 month prior to study start
- All other topical medications to face (e.g., steroids, antimicrobials, salicylic acid and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation
- Subjects will not apply any emollients and cosmetics to the facial area 24 hours prior to study initiation
- Subject must not be planning to become pregnant or nursing before entering the study and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms.
You may not qualify if:
- Subjects who are pregnant or nursing
- Subjects who have a grade 1 or more for facial erythema
- Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy
- Subjects who have a history of hypersensitivity to any of the formulation components
- Subjects who have received any experimental drug or used any experimental device 30 days prior to initiation of study therapy
- Subjects who have excessive facial hair that may obstruct or hinder the evaluation of any reactions
- Subjects who use any known photosensitizing agents
- Subjects who presently have skin cancer or actinic keratosis on the face
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Skin Study Center
Broomall, Pennsylvania, 19008, United States
Related Publications (1)
Leyden JJ, Nighland M, Rossi AB, Ramaswamy R. Irritation potential of tretinoin gel microsphere pump versus adapalene plus benzoyl peroxide gel. J Drugs Dermatol. 2010 Aug;9(8):998-1003.
PMID: 20684151RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Lineberry, Associate Director, Clinical Operations
- Organization
- Valeant Pharmaceuticals International Inc
Study Officials
- STUDY DIRECTOR
David Lineberry
Bausch Health Americas, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
July 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
February 15, 2012
Results First Posted
April 9, 2010
Record last verified: 2012-02