Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face
This study has been completed.
Sponsor:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00919191
First received: June 10, 2009
Last updated: February 14, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Tretinoin gel Drug: Adapalene and Benzoyl peroxide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using A Split-Face Model |
Resource links provided by NLM:
Further study details as provided by Valeant Pharmaceuticals International, Inc.:
Primary Outcome Measures:
- Comparative Assessment of Facial Irritation and Cutaneous Effects. [ Time Frame: Daily, for 3 weeks ] [ Designated as safety issue: No ]Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe
Secondary Outcome Measures:
- Self Assessment of Burning/Stinging and Itching [ Time Frame: Daily, for 3 weeks ] [ Designated as safety issue: No ]Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe
| Enrollment: | 26 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Two interventions in split-face model
Once daily use in a split face model:
|
Drug: Tretinoin gel
Tretinoin gel 0.04% used once daily in a split-face model
Other Name: Retin-A Micro Gel 0.04% Pump
Drug: Adapalene and Benzoyl peroxide
Adapalene .1% and Benzoyl peroxide 2.5%
Other Name: Epiduo Gel
|
Detailed Description:
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 listed in Appendix 1.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919191
Locations
| United States, Pennsylvania | |
| Skin Study Center | |
| Broomall, Pennsylvania, United States, 19008 | |
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
| Study Director: | Ana Rossi, MD | Johnson & Johnson Consumer and Personal Products Worldwide |
More Information
Additional Information:
Publications:
| Responsible Party: | Valeant Pharmaceuticals International, Inc. |
| ClinicalTrials.gov Identifier: | NCT00919191 History of Changes |
| Other Study ID Numbers: | CA-P-6805 |
| Study First Received: | June 10, 2009 |
| Results First Received: | December 28, 2009 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Valeant Pharmaceuticals International, Inc.:
|
acne irritation objective sensory methods |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Adapalene Benzoyl Peroxide Tretinoin Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
Antineoplastic Agents Keratolytic Agents 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 June 18, 2013