An observational study in Acne, sponsored by Cosmetique Active International. Completed at 1 site in Brazil. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by Cosmetique Active International · Observational
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.
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 35 is below the median of 90 across 81 observational studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult female or males with subjects with truncal acne
Exclusion Criteria:
daily use
Investigator global assessment
Scale 0=absent to 5=very serious
Time frame: baseline
Investigator global assessment
Scale 0=absent to 5=very serious
Time frame: Day 42
Investigator global assessment
Scale 0=absent to 5=very serious
Time frame: Day 84
inflammatory lesion count
count and percentage reduction
Time frame: baseline
inflammatory lesion count
count and percentage reduction
Time frame: Day 42
inflammatory lesion count
count and percentage reduction
Time frame: Day 84
non-inflammatory lesion count
count and percentage reduction
Time frame: baseline
non-inflammatory lesion count
count and percentage reduction
Time frame: Day 42
non-inflammatory lesion count
count and percentage reduction
Time frame: Day 84
total lesion count
count and percentage reduction
Time frame: baseline
total lesion count
count and percentage reduction
Time frame: Day 42
total lesion count
count and percentage reduction
Time frame: Day 84
acne severity
scale 0=absent to 5=very severe
Time frame: baseline
acne severity
scale 0=absent to 5=very severe
Time frame: Day 42
acne severity
scale 0=absent to 5=very severe
Time frame: Day 84
transepidermal water loss
tewameter assessment
Time frame: baseline
transepidermal water loss
tewameter assessment
Time frame: Day 42
transepidermal water loss
tewameter assessment
Time frame: Day 84
clinical safety
assessment of clinical signs symptoms and adverse events
Time frame: baseline
clinical safety
assessment of clinical signs symptoms and adverse events
Time frame: Day 42
clinical safety
assessment of clinical signs symptoms and adverse events
Time frame: Day 84
subject efficacy perception
scale 0=none to 5= very good
Time frame: Day 42
subject efficacy perception
scale 0=none to 5= very good
Time frame: Day 84
subject product perception
sacle 0=bad to 5 very good
Time frame: Day 84
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Cosmetique Active International