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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05601960
Enrollment
1785
Registered
2022-11-01
Start date
2020-04-15
Completion date
2021-02-28
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne, Postinflammatory Hyperpigmentation

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.

Interventions

OTHERanti-acne dermocosmetic

Topical application once daily for 2 months

Sponsors

Cosmetique Active International
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* less than 18 years * severe acne

Design outcomes

Primary

MeasureTime frameDescription
non-inflammatory lesionsbaselinelesion count
seborrhoea levelbaselinevisual analog scale scale 0=none to 10= very severe
acne severitybaselineGEA (Global evaluation of acne) scale 0=none to 5=very severe
PAHPI: post-acne hyperpigmentation indexbaselinepost-acne hyperpigmentation index from \<3mm to \>10mm
inflammatory lesionsbaselinelesion count

Secondary

MeasureTime frameDescription
Investigator satisfaction acneMonth 2visual analog scale from very unsatified=0 to very satisfied=5
Investigator satisfactionMonth 2visual analog scale from very unsatified=0 to very satisfied=5
Patient satisfaction acneMonth 2visual analog scale from very unsatified=0 to very satisfied=5
Patient satisfaction PAHPIMonth 2visual analog scale from very unsatified=0 to very satisfied=5
Patient: Skin qualityMonth 2visual analog scale from very unsatified=0 to very satisfied=5

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026