A Combination Treatment Reduces Acne Severity and PIHP

Study Overview
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Brief Summary
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Acne is a chronic, inflammatory skin condition. It may cause scars and post-inflammatory hyperpigmentation (PIHP). PIHP frequently affects individuals with a phototype of IV or above.[1] PIHP is worsened by UV radiation, lasts for years and impacts the individual well-being.[2, 3] In an observational study, 1785 adults with a phototype ranging from IV to VI with acne and PIHP applied daily for 2 months a dermocosmetic and a tainted sunscreen product (DC, Effaclar® Duo (+); SS, Anthelios® Shaka Fluide SPF 50+, SS; both La Roche-Posay Laboratoire Dermatologique, France.

Official Title
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A Combination of a Dermocosmetic and a Tainted Sunscreen Reduce Acne Severity and Signs of Post-inflammatory Hyperpigmentation in Subjects With a Fitzpatrick Phototype Ranging From IV to VI

Conditions
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Acne, Postinflammatory Hyperpigmentation

Intervention / Treatment
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* Other: anti-acne dermocosmetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult mild to moderate acne presence of postinflammatory hyperpigmentation lesions phototype IV to VI Exclusion Criteria: less than 18 years severe acne

Ages Eligible for Study
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Minimum Age: 18 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: anti-acne dermocosmetic|Topical application once daily for 2 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seborrhoea level | visual analog scale scale 0=none to 10= very severe | baseline | 
| seborrhoea level | visual analog scale 0=none to 10= very severe | Month 2 | 
| acne severity | GEA (Global evaluation of acne) scale 0=none to 5=very severe | baseline | 
| acne severity | GEA (Global evaluation of acne) scale 0=none to 5=very severe | Month 2 | 
| PAHPI: post-acne hyperpigmentation index | post-acne hyperpigmentation index from <3mm to >10mm | baseline | 
| PAHPI: post-acne hyperpigmentation index | post-acne hyperpigmentation index from <3mm to >10mm | Month 2 | 
| inflammatory lesions | lesion count | baseline | 
| inflammatory lesions | lesion count | Month 2 | 
| non-inflammatory lesions | lesion count | baseline | 
| non-inflammatory lesions | lesion count | Month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator satisfaction acne | visual analog scale from very unsatified=0 to very satisfied=5 | Month 2 | 
| Investigator satisfaction | visual analog scale from very unsatified=0 to very satisfied=5 | Month 2 | 
| Patient satisfaction acne | visual analog scale from very unsatified=0 to very satisfied=5 | Month 2 | 
| Patient satisfaction PAHPI | visual analog scale from very unsatified=0 to very satisfied=5 | Month 2 | 
| Patient: Skin quality | visual analog scale from very unsatified=0 to very satisfied=5 | Month 2 |