A Combination Treatment Reduces Acne Severity and PIHP

Sponsor

Cosmetique Active International (Industry)

Overall Status

Completed

CT.gov ID

NCT05601960

Collaborator

(none)

1,785

Enrollment

Location

10.5

Actual Duration (Months)

170.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Postinflammatory Hyperpigmentation	Other: anti-acne dermocosmetic

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1785 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 15, 2020

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2021

Outcome Measures

Primary Outcome Measures

seborrhoea level [baseline]
visual analog scale scale 0=none to 10= very severe
seborrhoea level [Month 2]
visual analog scale 0=none to 10= very severe
acne severity [baseline]
GEA (Global evaluation of acne) scale 0=none to 5=very severe
acne severity [Month 2]
GEA (Global evaluation of acne) scale 0=none to 5=very severe
PAHPI: post-acne hyperpigmentation index [baseline]
post-acne hyperpigmentation index from <3mm to >10mm
PAHPI: post-acne hyperpigmentation index [Month 2]
post-acne hyperpigmentation index from <3mm to >10mm
inflammatory lesions [baseline]
lesion count
inflammatory lesions [Month 2]
lesion count
non-inflammatory lesions [baseline]
lesion count
non-inflammatory lesions [Month 2]
lesion count

Secondary Outcome Measures

Investigator satisfaction acne [Month 2]
visual analog scale from very unsatified=0 to very satisfied=5
Investigator satisfaction [Month 2]
visual analog scale from very unsatified=0 to very satisfied=5
Patient satisfaction acne [Month 2]
visual analog scale from very unsatified=0 to very satisfied=5
Patient satisfaction PAHPI [Month 2]
visual analog scale from very unsatified=0 to very satisfied=5
Patient: Skin quality [Month 2]
visual analog scale from very unsatified=0 to very satisfied=5

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

less than 18 years
severe acne

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	L'Oreal	Dubai		United Arab Emirates

Sponsors and Collaborators

Cosmetique Active International

Investigators

Principal Investigator: Rana Shabab, Dermatique Skin Care, Khobar, KSA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cosmetique Active International

ClinicalTrials.gov Identifier:

NCT05601960

Other Study ID Numbers:

LRP19009

First Posted:

Nov 1, 2022

Last Update Posted:

Nov 1, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperpigmentation

Sunscreening Agents

Study Results

No Results Posted as of Nov 1, 2022