A Combination Treatment Reduces Acne Severity and PIHP

Completed

• Conditions: Acne; Postinflammatory Hyperpigmentation

• Registration Number: NCT05601960
• Lead Sponsor: Cosmetique Active International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2022-10
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study First Posted: 2022-11-01
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1785

Inclusion Criteria

• adult
• mild to moderate acne
• presence of postinflammatory hyperpigmentation lesions
• phototype IV to VI

Exclusion Criteria

• less than 18 years
• severe acne

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Investigator satisfaction acne	Month 2	visual analog scale from very unsatified=0 to very satisfied=5
Investigator satisfaction	Month 2	visual analog scale from very unsatified=0 to very satisfied=5
Patient satisfaction PAHPI	Month 2	visual analog scale from very unsatified=0 to very satisfied=5
Patient: Skin quality	Month 2	visual analog scale from very unsatified=0 to very satisfied=5
Patient satisfaction acne	Month 2	visual analog scale from very unsatified=0 to very satisfied=5

Trial Locations

Locations (1)

L'Oreal; 🇦🇪 Dubai, United Arab Emirates