A Combination Treatment Reduces Acne Severity and PIHP

October 31, 2022 updated by: Cosmetique Active International

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1785

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult subjects with mild to moderate acne, post-inflammatory hyperpigmentation and of any phototype were suitable for this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator satisfaction acne
Time Frame: Month 2
visual analog scale from very unsatified=0 to very satisfied=5
Month 2
Investigator satisfaction
Time Frame: Month 2
visual analog scale from very unsatified=0 to very satisfied=5
Month 2
Patient satisfaction acne
Time Frame: Month 2
visual analog scale from very unsatified=0 to very satisfied=5
Month 2
Patient satisfaction PAHPI
Time Frame: Month 2
visual analog scale from very unsatified=0 to very satisfied=5
Month 2
Patient: Skin quality
Time Frame: Month 2
visual analog scale from very unsatified=0 to very satisfied=5
Month 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cosmetique Active International

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRP19009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne

Clinical Trials on anti-acne dermocosmetic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe