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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,785
- Locations
- 1
- Primary Endpoint
- inflammatory lesions
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •mild to moderate acne
- •presence of postinflammatory hyperpigmentation lesions
- •phototype IV to VI
Exclusion Criteria
- •less than 18 years
- •severe acne
Outcomes
Primary Outcomes
inflammatory lesions
Time Frame: Month 2
lesion count
PAHPI: post-acne hyperpigmentation index
Time Frame: Month 2
post-acne hyperpigmentation index from \<3mm to \>10mm
seborrhoea level
Time Frame: Month 2
visual analog scale 0=none to 10= very severe
acne severity
Time Frame: Month 2
GEA (Global evaluation of acne) scale 0=none to 5=very severe
non-inflammatory lesions
Time Frame: Month 2
lesion count
Secondary Outcomes
- Investigator satisfaction acne(Month 2)
- Investigator satisfaction(Month 2)
- Patient satisfaction PAHPI(Month 2)
- Patient: Skin quality(Month 2)
- Patient satisfaction acne(Month 2)