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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acne

Intervention / Treatment
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* Other: Deep Cleansing Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: above 18 years truncal acne Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Deep Cleansing Gel|daily use|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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truncal acne