Phase 4
N=26
Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00919191 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Comparative Assessment of Facial Irritation and Cutaneous Effects. — 1.1; 2.7; 3.2; 6.2 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tretinoin gel (Drug); Adapalene and Benzoyl peroxide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparative Assessment of Facial Irritation and Cutaneous Effects. |
1.1; 2.7; 3.2; 6.2 | — |
| SECONDARY Self Assessment of Burning/Stinging and Itching |
1.4; 3.7; 0.7; 1.9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00919191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.