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Clinical Trials/NCT05601960
NCT05601960CompletedNot Applicable

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

Cosmetique Active International1 site in 1 country1,785 target enrollmentStarted: April 15, 2020Last updated:
Conditions

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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