Clinical trial NCT05584150: The Benefit of a Deep Cleansing Gel in the Management of Mild to Moderate Truncal Acne
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne
Keywords: truncal acne
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult female or males with subjects with truncal acne

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.

Eligibility criteria: Inclusion Criteria:

* above 18 years
* truncal acne

Exclusion Criteria:

- None

Primary outcomes:
measure: Investigator global assessment
timeFrame: baseline
measure: Investigator global assessment
timeFrame: Day 42
measure: Investigator global assessment
timeFrame: Day 84
Secondary outcomes:
measure: inflammatory lesion count
timeFrame: baseline
measure: inflammatory lesion count
timeFrame: Day 42
measure: inflammatory lesion count
timeFrame: Day 84
measure: non-inflammatory lesion count
timeFrame: baseline
measure: non-inflammatory lesion count
timeFrame: Day 42
measure: non-inflammatory lesion count
timeFrame: Day 84
measure: total lesion count
timeFrame: baseline
measure: total lesion count
timeFrame: Day 42
measure: total lesion count
timeFrame: Day 84
measure: acne severity
timeFrame: baseline
measure: acne severity
timeFrame: Day 42
measure: acne severity
timeFrame: Day 84
measure: transepidermal water loss
timeFrame: baseline
measure: transepidermal water loss
timeFrame: Day 42
measure: transepidermal water loss
timeFrame: Day 84
measure: clinical safety
timeFrame: baseline
measure: clinical safety
timeFrame: Day 42
measure: clinical safety
timeFrame: Day 84
measure: subject efficacy perception
timeFrame: Day 42
measure: subject efficacy perception
timeFrame: Day 84
measure: subject product perception
timeFrame: Day 84
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: CIDP
Study officials:
affiliation: La Roche-Posay Laboratoire Dermatologique
name: Delphine Kerob, MD
role: STUDY_DIRECTOR
References: