Introduction

Dapsone is a sulphone with anti-inflammatory properties. It scavenges reactive oxygen species and minimizes associated inflammation. Adapalene and benzoyl peroxide are often used in combination with other acne treatments. Adapalene has more favourable tolerance profile than other topical retinoids.

Aim

To evaluate the safety and efficacy of dapsone gel 5%, in treatment of acne when used in combination with adapalene gel 0.1% or benzoyl peroxide gel 4% or moisturizer.

Patient Profile

• Male and female patients 12 years of age or older with clinical diagnosis of acne vulgaris involving face
• Global Acne assessment Score of at least 2 at baseline and minimum of 20 inflammatory lesions ( defined to include papules and pustules) and 20 non-inflammatory lesion (comedones) above mandibular line at baseline

Method

 Study Design

• Randomized
• Double blind study

Study Endpoints

• Primary efficacy endpoints
  • The mean percentage reduction from baseline in inflammatory acne lesion counts at week 12
• Secondary efficacy endpoints
  • Mean percentage reduction from baseline for inflammatory, non-inflammatory and total acne lesion counts
  • Incidence of success based on the GAAS
• Definition
  • Incidence of success based on the 5-point GAAS scale was defined as a rating of zero (none or no evidence of facial acne vulgaris )or 1 (minimal , where a few non-inflammatory lesions are present and few inflammatory lesions may be present
  • The total lesion count was the sum of inflammatory and non-inflammatory lesions

Results

• Dapsone gel in combination with any three treatments reduced the number of inflammatory lesions from baseline

_*P=0.052

• Significantly better response observed with dapsone gel + adapalene compared to dapsone gel + moisturizer for both non-inflammatory and total acne lesion counts (p<0.001 and p=0.004)
• Overall efficacy in all treatment groups for all lesions categories (inflammatory, non-inflammatory and total lesion) was observed as early as week 2 and showed further improvement throughout the 12 week period
• Dapsone gel +adapalene showed significant better results compared to the dapsone gel +moisturizer combination (p=0.0395) in terms of GAAS treatment success

Safety

• Local adverse reactions were generally mild and improved during treatment
• Mean plasma dapsone and N-acetyl dapsone concentrations were low and remained low throughout the study.

 Conclusion

• Dapsone gel 5% in combination with either adapalene gel 0.1% or benzoyl peroxide gel 4% was safe and well tolerated in the treatment of acne vulgaris.

J Drugs Dermatol. 2010 Jan; 9(1):33-40