The Benefit of a Deep Cleansing Gel in the Management of Mild to Moderate Truncal Acne

Completed

• Conditions: Acne

• Registration Number: NCT05584150
• Lead Sponsor: Cosmetique Active International

Brief Summary

Acne vulgaris is a chronic inflammatory disease, mainly of the face, but also of the trunk. Acne may be caused by internal and external factors. Only a very small amount of data exists concerning truncal acne. The condition affects about 9% of the population worldwide, with 50% of subjects with facial acne also presenting with truncal acne. Until recently, clinicians frequently followed the same therapeutic approach as for facial acne, with treatment adherence remaining an issue.

This study assessed assessed the benefit of a cleansing gel containing salicylic acid 2%, zinc gluconate 0.2% and Lipo hydroxy acids (LHA) 0.05%, used daily for 84 days in mild to moderate truncal acne.

Detailed Description

For this single center, open label, non-randomized exploratory study, 51 subjects with mild to moderate truncal acne were recruited. The study received ethics committee approval. All subjects provided written informed consent. The investigator evaluated the number of inflammatory, non-inflammatory and total lesions at Baseline, Day 42 and 84. Skin barrier function was appraised via the assessment of transepidermal water loss (TEWL) using a Tewameter® (Courage + Khazaka Electronic GmbH, Germany). Safety was assessed by considering the evaluation of clinical signs and reporting of symptoms, and local adverse reactions. Subjects were asked to gently massage the wet skin of the trunk with the product in the morning and evening for at least 30 seconds, and then thoroughly rinse with tempered water and pat dry.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• above 18 years
• truncal acne

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigator global assessment	Day 84	Scale 0=absent to 5=very serious

Secondary Outcome Measures

Name	Time	Method
inflammatory lesion count	Day 84	count and percentage reduction
non-inflammatory lesion count	Day 84	count and percentage reduction
total lesion count	Day 84	count and percentage reduction
acne severity	Day 84	scale 0=absent to 5=very severe
transepidermal water loss	Day 84	tewameter assessment
clinical safety	Day 84	assessment of clinical signs symptoms and adverse events
subject efficacy perception	Day 84	scale 0=none to 5= very good
subject product perception	Day 84	sacle 0=bad to 5 very good

Trial Locations

Locations (1)

CIDP; 🇧🇷 Rio de Janeiro, Brazil