Efficacy of a Deep Cleansing Gel Containing 2% Salicylic Acid, 0.2% Zinc Gluconate and 0.05% Lipohydroxy Acid in the Management of Mild to Moderate Facial Acne

March 9, 2023 updated by: Cosmetique Active International

ASSESSMENT OF CLINICAL, INSTRUMENTAL AND NOTICED EFICACY BY SUBJECTS OF A COSMETIC PRODUCT 12.0417.01.090 UNDER NORMAL CONDITIONS OF USE Study With Dermatological Follow-up Including Instrumental Measurements

A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. The clinical evaluation considered in oiliness, shininess and global aspect of the skin too. Instrumental assessment of oiliness and shininess was performed, respectively, by Sebumeter and Sebutape.

IThe tested cleanser was used twice daily (morning and evening) during 28 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

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

  • Brazil
      • Niterói, Brazil, 20231-048
        • Carlos Tortely Hospital

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

13 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects aged between 13 to 25 years of age with mild to moderate acne.

Description

Inclusion Criteria:

  • subjects aged 13-25 years
  • mild to moderate acne on the face
  • signed informed consent

Exclusion Criteria:

  • subjects below 13 years and above 26 years
  • severe acne on the face

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global lesion count
Time Frame: baseline
using GEA scale
baseline
Global lesion count
Time Frame: Day 28
using GEA scale
Day 28
Closed comedones
Time Frame: baseline
count
baseline
Closed comedones
Time Frame: Day 28
count
Day 28
papules
Time Frame: baseline
count
baseline
papules
Time Frame: Day 28
count
Day 28
skin oiliness
Time Frame: baseline
instrumental measurement Sebumeter
baseline
skin oiliness
Time Frame: Day 28
instrumental measurement Sebumeter
Day 28
skin sebutape
Time Frame: baseline
instrumental measurement Sebumeter
baseline
skin sebutape
Time Frame: Day 28
instrumental measurement Sebumeter
Day 28
subject satisfaction
Time Frame: Day 28
questionnaire
Day 28

Collaborators and Investigators

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

Sponsor

Cosmetique Active International

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 8, 2013

Primary Completion (Actual)

July 22, 2013

Study Completion (Actual)

July 22, 2013

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090.324.003.12

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.

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