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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05601960
Other study ID # LRP19009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date February 28, 2021

Study information

Verified date October 2022
Source Cosmetique Active International
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1785
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
anti-acne dermocosmetic
Topical application once daily for 2 months

Locations

Country Name City State
United Arab Emirates L'Oreal Dubai

Sponsors (1)

Lead Sponsor Collaborator
Cosmetique Active International

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary seborrhoea level visual analog scale scale 0=none to 10= very severe baseline
Primary seborrhoea level visual analog scale 0=none to 10= very severe Month 2
Primary acne severity GEA (Global evaluation of acne) scale 0=none to 5=very severe baseline
Primary acne severity GEA (Global evaluation of acne) scale 0=none to 5=very severe Month 2
Primary PAHPI: post-acne hyperpigmentation index post-acne hyperpigmentation index from <3mm to >10mm baseline
Primary PAHPI: post-acne hyperpigmentation index post-acne hyperpigmentation index from <3mm to >10mm Month 2
Primary inflammatory lesions lesion count baseline
Primary inflammatory lesions lesion count Month 2
Primary non-inflammatory lesions lesion count baseline
Primary non-inflammatory lesions lesion count Month 2
Secondary Investigator satisfaction acne visual analog scale from very unsatified=0 to very satisfied=5 Month 2
Secondary Investigator satisfaction visual analog scale from very unsatified=0 to very satisfied=5 Month 2
Secondary Patient satisfaction acne visual analog scale from very unsatified=0 to very satisfied=5 Month 2
Secondary Patient satisfaction PAHPI visual analog scale from very unsatified=0 to very satisfied=5 Month 2
Secondary Patient: Skin quality visual analog scale from very unsatified=0 to very satisfied=5 Month 2
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