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

Acne Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05584150
• Other study ID #: 1819CBCL747
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2022
• Source: Cosmetique Active International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• above 18 years

• truncal acne

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Other:
• Deep Cleansing Gel
daily use

Locations

Country	Name	City	State
Brazil	CIDP	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator global assessment	Scale 0=absent to 5=very serious	baseline
Primary	Investigator global assessment	Scale 0=absent to 5=very serious	Day 42
Primary	Investigator global assessment	Scale 0=absent to 5=very serious	Day 84
Secondary	inflammatory lesion count	count and percentage reduction	baseline
Secondary	inflammatory lesion count	count and percentage reduction	Day 42
Secondary	inflammatory lesion count	count and percentage reduction	Day 84
Secondary	non-inflammatory lesion count	count and percentage reduction	baseline
Secondary	non-inflammatory lesion count	count and percentage reduction	Day 42
Secondary	non-inflammatory lesion count	count and percentage reduction	Day 84
Secondary	total lesion count	count and percentage reduction	baseline
Secondary	total lesion count	count and percentage reduction	Day 42
Secondary	total lesion count	count and percentage reduction	Day 84
Secondary	acne severity	scale 0=absent to 5=very severe	baseline
Secondary	acne severity	scale 0=absent to 5=very severe	Day 42
Secondary	acne severity	scale 0=absent to 5=very severe	Day 84
Secondary	transepidermal water loss	tewameter assessment	baseline
Secondary	transepidermal water loss	tewameter assessment	Day 42
Secondary	transepidermal water loss	tewameter assessment	Day 84
Secondary	clinical safety	assessment of clinical signs symptoms and adverse events	baseline
Secondary	clinical safety	assessment of clinical signs symptoms and adverse events	Day 42
Secondary	clinical safety	assessment of clinical signs symptoms and adverse events	Day 84
Secondary	subject efficacy perception	scale 0=none to 5= very good	Day 42
Secondary	subject efficacy perception	scale 0=none to 5= very good	Day 84
Secondary	subject product perception	sacle 0=bad to 5 very good	Day 84