Back issues No.4 - 1997 / Original Study  
 
 

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Double Blind Clinical Trial of 0.05% Isotretinoin gel and 0.05% Tretinoin cream for Treatment of Acne
Chen-Nai Wang, Heng-Leong Chan
Dermatol Sinica 15: 242-248, 1997

This was a randomised, double-blind, parallel-group study to compare the efficacy and tolerance of 0.05% isotretinoin gel (ISOTREX) with 0.05% tretinoin cream (Retin-A) in the treatment of acne. A total of 60 patients (10 males and 50 females), aged from 15 to 30 years, were entered into the 3 month study that was carried out from September 1994 to January 1995. Complete data from 59 patients (30 patients from the Retin-A group and 29 from the ISOTREX group) were available for evaluation. Both treatments were equally effective in reducing acne severity. In both the investigator’s and patients’ overall assessments of efficacy at the end of the trial, there was no significant difference between the two treatment groups. 80% of patients in the Retin-A group and 79% of patients in the ISOTREX group rated the efficacy as good or very good. For both the investigator’s and patients’ overall assessments of treatment tolerance. Again the tolerance was similar for both treatments. In the Retin-A group 70% of patients assessed tolerance as good or very good compared with 66% of patients in the ISOTREX group. In the ISOTREX group. About 10% of patients rated tolerance as poor compared to none from the Retin-A group. The dropout rate for the ISOTREX group at 17% was slightly higher than the Retin-A group at 13%. The incidence of retinoid dermatitis was 83% in the ISOTREX group compared with 93% in the Retin-A group and the symptoms normally lasted for one to two weeks in both teatment groups. The most common symptom experienced by patients in both groups was scaling, and severity ranged from mild to moderate. This was reported by 86% of patients in the Retin-A group and 79% of patients in the ISOTREX group. The recurrence rate of retinoid dermatitis in the ISOTREX group at 33% was much lower much lower compared to 60% in the Retin-A group. The results of this study comfirmed that both ISOTREX group and Retin-A were equally effective in the treatment of acne. However, the tolerance of individual symptoms by the patients in the two treatment groups varies and this needs to be further investigated.

   
   
 
 
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