A Combination Treatment Reduces Acne Severity and PIHP
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
1 other identifier
observational
1,785
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedFirst Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
November 1, 2022
CompletedNovember 1, 2022
October 1, 2022
11 months
October 25, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (10)
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 Outcomes (5)
Investigator satisfaction acne
Month 2
Investigator satisfaction
Month 2
Patient satisfaction acne
Month 2
Patient satisfaction PAHPI
Month 2
Patient: Skin quality
Month 2
Interventions
Eligibility Criteria
Adult subjects with mild to moderate acne, post-inflammatory hyperpigmentation and of any phototype were suitable for this study.
You may qualify if:
- adult
- mild to moderate acne
- presence of postinflammatory hyperpigmentation lesions
- phototype IV to VI
You may not qualify if:
- less than 18 years
- severe acne
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
L'Oreal
Dubai, United Arab Emirates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rana Shabab
Dermatique Skin Care, Khobar, KSA
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2022
First Posted
November 1, 2022
Study Start
April 15, 2020
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share