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

NCT ID: NCT05584150

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-11-30

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.

Conditions

Acne

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Deep Cleansing Gel

daily use

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• above 18 years
• truncal acne

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cosmetique Active International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delphine Kerob, MD

Role: STUDY_DIRECTOR

La Roche-Posay Laboratoire Dermatologique

Locations

CIDP

Rio de Janeiro, , Brazil

Countries

Brazil

References

Towersey L, Correia P, Fajgenbaum Feiges M, Euzebio Goncalves Junior J, Sant'Anna B, Kerob D, Le Floc'h C. Assessment of the Benefit of a Deep Cleansing Gel Containing Salicylic Acid 2%, Zinc Gluconate 0.2% and Lipohydroxy Acids 0.05% in Patients with Mild to Moderate Truncal Acne: Results from an Exploratory Study. Clin Cosmet Investig Dermatol. 2023 Jan 18;16:119-123. doi: 10.2147/CCID.S394123. eCollection 2023.

Reference Type: DERIVED

PMID: 36698447 (View on PubMed)

Other Identifiers

1819CBCL747

Identifier Type: -

Identifier Source: org_study_id