Efficacy of a spray formulation in acne of the chest and back

Phase 3

Completed

• Conditions: Skin and Connective Tissue Diseases; Truncal acne vulgaris

• Registration Number: ISRCTN38383374
• Lead Sponsor: Difa Cooper

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-05
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Aged 18 years and over
2. Presence of mild to moderate acne involving back and chest regions (truncal acne)

Exclusion Criteria

1. Severe forms of acne requiring systemic treatments
2. Other severe skin conditions
3. Use of topical acne medications such as tretinoin, benzoyl peroxide or topical antibiotics within 2 weeks
4. Use of oral antibiotics within 30 days
5. Use of systemic corticosteroids within 4 weeks
6. Body Mass Index >30

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical evolution of acne lesions is measured using the Global Acne Grading System (GAGS) at baseline and 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Skin tolerability is measured by evaluating skin irritation (erythema and burning) and skin xerosis using a quantitative score from 0(no symptom) to 3(relevant symptom) at 6 weeks.