A Combination Treatment Reduces Acne Severity and PIHP

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601960
• Other study ID #: LRP19009
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Acne
• Hyperpigmentation
• Postinflammatory Hyperpigmentation

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