Efficacy and Safety of Topical Dapsone 5% Gel in Indian Patients with Mild to Moderate Acne

24 Oct, 16

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Introduction

Dapsone is a synthetic sulfone administered orally for the treatment of certain skin diseases like leprosy, dermatitis herpetiformis etc. It has both antimicrobial and anti-inflammatory properties. Topical dapsone 5% gel has been approved by the US FDA for the treatment of acne.

Aim

To evaluate the safety and efficacy of topical 5% dapsone gel in Indian patients with acne.

Patient Profile

N=160 Indian patients with acne vulgaris
82 females and 78 males
Mean age of patient = 28 years (youngest 14 years and oldest 42 years)

Study Design

Open, non-comparative study

Table 1: Global acne assessment score

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None

No evidence of facial acne vulgaris

I

Minimal

Few non-inflammatory lesions (comedones) are present; a few

inflammatory lesions (papules/pustules) may be present

II

Mild

Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present

III

Moderate

Many non-inflammatory (comedones) and inflammatory lesions

(papules/pustules) are present; no nodulocystic lesions are allowed

IV

Severe

Severe significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulocystic lesions may be present; comedones may be present

Assessment of efficacy and safety was conducted at the end of 2, 4 and 6 weeks
The assessment was done as per the parameters of efficacy, safety, and patient’s satisfaction and scored from 0-100.
- >75% = Excellent response
- 50%-75% = Good response
- 25%-49% = Fair response
- <25% = Poor response

Results

Efficacy

At Week 6, overall response to dapsone
- Good response was seen in 40 % patients
- 60.6% of patients showed excellent to good response
- 16.2% of patients showed fair response
- 7.2 % had poor response

Figure 1: Efficacy of dapsone at week 6

Safety

At the end of week 6, 96% of patients rated dapsone gel tolerability as either excellent or good. Of the 160 patients, 3.8% patients had mild adverse effect on the application site.

Conclusions

Dapsone gel demonstrated good efficacy, safety, and tolerability in the Indian skin type. It's high efficacy and compatibility with other concurrent acne medications make topical dapsone a key component in the treatment of acne.

International Journal of Universal Pharmacy and Life Sciences.2012; 2(2):74-9

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