Comparison of the efficacy, safety and tolerability of topically applied tretinoin formulated with TPM, a lead commercially available tretinoin cream and a vehicle (placebo) in the treatment of mild to moderate acne vulgaris

Phase 2

Completed

• Conditions: Treatment of acne vulgaris; Skin - Dermatological conditions

• Registration Number: ACTRN12613000756729
• Lead Sponsor: Phosphagenics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

* Minimum of 15 and Maximum of 60 inflammatory lesions on the face (papules and/ or pustules) and no more than one small nodulocystic lesion;
* Existence of a minimum of 50 non-inflammatory lesions on the face (blackheads/whiteheads);
* A score of 2 or 3 on the Investigator's Global Assessment (IGA) scale;
* Willing to minimise exposure to the sun, and avoid tanning booths and solariums

Exclusion Criteria

* Severe acne vulgaris
* Facial skin condition other than acne vulgaris
* Facial hair, excessive scarring, sunburn or other disfigurement that may obscure assessment of acne counts or severity
* History of retinoid intolerance
* Subjects that are on topical/systemic acne treatment that does not meet the washout period
* Nursing/pregnant women
* The women were planning for pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean absolute change in total acne lesion count <br><br>Lesion count will be scored by a dermatologist during clinical examination.[From Baseline to Week 12.];The percent of subjects with a successful outcome on a global acne grading scale.<br><br>Success on the Acne Global Severity Scale is a reduction of 2 from baseline.[Week 12.]