Efficacy and Tolerance of Formula 609613 37 in Acneic Patients

July 19, 2022 updated by: Cosmetique Active International

Evaluation of the Efficacy and Tolerance of Formula 609613 37 in Acneic Patients as an Adjunct to and in Addition to 5% Benzoyl Peroxide for 6 Months

Acne affects most adolescents and young adults with varying severity and presentation. For early or localized forms, the first-line treatment is usually local. The available treatments often lead to local irritation, particularly during the first few weeks of use. This is why creams containing exfoliating agents have long been used in acne, as they are considered to allow a faster disappearance of superficial lesions.

The objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide gel.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee).

Regarding the statistical analysis, two different analysis are performed:

  • Descriptive analysis: quantitative variables are described by the mean and standard deviation and qualitative variables by the raw number of each modality and the corresponding percentage.
  • Comparative analysis: for quantitative variables, inter-group comparisons are made by a Student's T-test or a non parametric Mann-Whitney test if necessary. For qualitative variables, comparisons are made using a Chi-square test, if the expected number of participants is less than 5, Fischer's exact test on a 4-box contingency tables is used.

A significant level of p <0.05 is considered as significant. A double-data entry is carried out then a comparison of the two databases is performed. Finally internal and external consistency tests are planned. Missing data are described and possibly analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acneic facial skin
  • between 20 and 50 non-inflammatory lesions on the face
  • between 10 and 40 superficial inflammatory lesions on the face
  • no local acneic treatment in the previous 15 days
  • no treatment with isotretinoin in the previous 3 months
  • agreeing to apply only the study products

Exclusion Criteria:

  • less than 20 or more than 50 non-inflammatory lesions on the face
  • less than 10 or more than 40 superficial inflammatory lesions on the face
  • prescription of a local acne treatment for less than 15 days
  • prescription of an antibiotic treatment for less than 1 month
  • prescription of an isotretinoin treatment for less than 3 months
  • changing toiletries and hygiene products regularly

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: moisturizing cream and 5% benzoyl peroxide gel
Participants apply the 5% benzoyl peroxide gel every evening and the moisturizing cream every morning for 3 months. Then they are divided into 2 groups: one applies the anti-acne face cream every morning for 3 months and the other one the moisturizing cream every morning for 3 months.
Other: moisturizing cream and 5% benzoyl peroxide gel

Group A: Eclaran 5% every evening and formula 609567 49 every morning, for 3 months.

Then the group is divided: Group A1/ formula 609613 37 and Group A2/ formula 609567 49 every morning, for the next 3 months
Experimental: anti-acne face cream and 5% benzoyl peroxide gel
Participants apply the 5% benzoyl peroxide gel every other night and the anti-acne face cream every morning for 3 months. Then they are divided into 2 groups: one applies the anti-acne face cream every morning for 3 months and the other one the moisturizing cream every morning for 3 months.
Other: anti-acne face cream and 5% benzoyl peroxide gel

Group B: Eclaran 5% every other night and 609613 37 every morning, for 3 months.

Then the group is divided: Group B1/ 609613 37 and Group B2/ formula 609567 49 every morning, for the next 3 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in the composite score
Time Frame: from baseline to month 6
the investigator evaluates i) the skin sensitivity (erythema, desquamation) and ii) the global tolerance on a 4-point scale (i) from Absent to Important and ii) from Nil to Excellent)
from baseline to month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in the lesion count
Time Frame: from baseline to month 6
counting of non-inflammatory (open and closed comedones) and inflammatory (papules, pustules) lesions
from baseline to month 6
change in the evaluation of skin sensitivity by the patient
Time Frame: from baseline to month 6
evaluation of the skin sensitivity (pruritus, tingling sensation, burning sensation) on a 4-point scale (from Absent to Important)
from baseline to month 6
change in the evaluation of global tolerance by the patient
Time Frame: from baseline to month 6
evaluation on a 4-point scale (from Nil to Excellent)
from baseline to month 6
change in the evaluation of the efficacy by the investigator and patient
Time Frame: from baseline to month 6
evaluation on a 4-point scale (from Nil to Excellent)
from baseline to month 6
change in the evaluation of the global efficacy by the investigator
Time Frame: from baseline to month 6
evaluation on a 6-point scale (from No lesion to Very severe)
from baseline to month 6
change in the quality of life
Time Frame: from baseline to month 6
evaluation of the quality of life of patients with the Cardiff Acne Disability Index (CADI) score
from baseline to month 6

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LRP09001-EFFACLAR DUO

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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