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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Other: Deep Cleansing Gel

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20231-048
    • CIDP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult female or males with subjects with truncal acne

Description

Inclusion Criteria:

• above 18 years
• truncal acne

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator global assessment	Scale 0=absent to 5=very serious	baseline
Investigator global assessment	Scale 0=absent to 5=very serious	Day 42
Investigator global assessment	Scale 0=absent to 5=very serious	Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory lesion count	count and percentage reduction	baseline
inflammatory lesion count	count and percentage reduction	Day 42
inflammatory lesion count	count and percentage reduction	Day 84
non-inflammatory lesion count	count and percentage reduction	baseline
non-inflammatory lesion count	count and percentage reduction	Day 42
non-inflammatory lesion count	count and percentage reduction	Day 84
total lesion count	count and percentage reduction	baseline
total lesion count	count and percentage reduction	Day 42
total lesion count	count and percentage reduction	Day 84
acne severity	scale 0=absent to 5=very severe	baseline
acne severity	scale 0=absent to 5=very severe	Day 42
acne severity	scale 0=absent to 5=very severe	Day 84
transepidermal water loss	tewameter assessment	baseline
transepidermal water loss	tewameter assessment	Day 42
transepidermal water loss	tewameter assessment	Day 84
clinical safety	assessment of clinical signs symptoms and adverse events	baseline
clinical safety	assessment of clinical signs symptoms and adverse events	Day 42
clinical safety	assessment of clinical signs symptoms and adverse events	Day 84
subject efficacy perception	scale 0=none to 5= very good	Day 42
subject efficacy perception	scale 0=none to 5= very good	Day 84
subject product perception	sacle 0=bad to 5 very good	Day 84

Collaborators and Investigators

• Sponsor: Cosmetique Active International
• Investigators: Study Director: Delphine Kerob, MD, La Roche-Posay Laboratoire Dermatologique

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: truncal acne
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 1819CBCL747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No