Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-27 @ 2:50 AM
Study NCT ID:
NCT05584150
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2022-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Benefit of a Deep Cleansing Gel in the Management of Mild to Moderate Truncal Acne
Sponsor:
Cosmetique Active International
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: