AcneNCT05469880
Efficacy and Tolerance of Formula 609613 37 in Acneic Patients
A study testing moisturizing cream and 5% benzoyl peroxide gel and anti-acne face cream and 5% benzoyl peroxide gel in people with Acne, run by Cosmetique Active International.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- moisturizing cream and 5% benzoyl peroxide gel and anti-acne face cream and 5% benzoyl peroxide gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2009to 25 May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Acne
- Being tested
- moisturizing cream and 5% benzoyl peroxide gel, anti-acne face cream and 5% benzoyl peroxide gel
- Keywords
- acne, lipohydroxyacid, salicylic acid, benzoyl peroxide, dermocosmetic
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moisturizing cream and 5% benzoyl peroxide gelOther
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
anti-acne face cream and 5% benzoyl peroxide gelOther
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
| Study group | Role | What they receive |
|---|---|---|
| moisturizing cream and 5% benzoyl peroxide gel | Active comparator | 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. Receives: Other: moisturizing cream and 5% benzoyl peroxide gel |
| anti-acne face cream and 5% benzoyl peroxide gel | Experimental | 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. Receives: Other: anti-acne face cream and 5% benzoyl peroxide gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the composite score
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)
Measured: from baseline to month 6
Secondary outcomes (6)
change in the lesion count
counting of non-inflammatory (open and closed comedones) and inflammatory (papules, pustules) lesions
Measured: from baseline to month 6
change in the evaluation of skin sensitivity by the patient
evaluation of the skin sensitivity (pruritus, tingling sensation, burning sensation) on a 4-point scale (from Absent to Important)
Measured: from baseline to month 6
change in the evaluation of global tolerance by the patient
evaluation on a 4-point scale (from Nil to Excellent)
Measured: from baseline to month 6
change in the evaluation of the efficacy by the investigator and patient
evaluation on a 4-point scale (from Nil to Excellent)
Measured: from baseline to month 6
change in the evaluation of the global efficacy by the investigator
evaluation on a 6-point scale (from No lesion to Very severe)
Measured: from baseline to month 6
change in the quality of life
evaluation of the quality of life of patients with the Cardiff Acne Disability Index (CADI) score
Measured: from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start21 Oct 2009
- Primary completion25 May 2010
- Study completion25 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469880
- Sponsor's protocol ID
- LRP09001-EFFACLAR DUO
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05469880
- Acronym / sponsor ID
- LRP09001-EFFACLAR DUO
- Conditions
- Acne
- Keywords
- acne, lipohydroxyacid, salicylic acid, benzoyl peroxide, dermocosmetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2009 (actual)
- Primary completion
- 25 May 2010 (actual)
- Study completion
- 25 May 2010 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moisturizing cream and 5% benzoyl peroxide gel | Active comparator | Other: moisturizing cream and 5% benzoyl peroxide gelParticipants 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. |
| anti-acne face cream and 5% benzoyl peroxide gel | Experimental | Other: anti-acne face cream and 5% benzoyl peroxide gelParticipants 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. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moisturizing cream and 5% benzoyl peroxide gelGroup 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 | Other | moisturizing cream and 5% benzoyl peroxide gel |
| anti-acne face cream and 5% benzoyl peroxide gelGroup 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 | Other | anti-acne face cream and 5% benzoyl peroxide gel |
Primary outcome
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)
6 secondary outcomes
change in the lesion count
Time frame: from baseline to month 6
change in the evaluation of skin sensitivity by the patient
Time frame: from baseline to month 6
change in the evaluation of global tolerance by the patient
Time frame: from baseline to month 6
change in the evaluation of the efficacy by the investigator and patient
Time frame: from baseline to month 6
change in the evaluation of the global efficacy by the investigator
Time frame: from baseline to month 6
change in the quality of life
Time frame: from baseline to month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing moisturizing cream and 5% benzoyl peroxide gel and anti-acne face cream and 5% benzoyl peroxide gel in people with Acne, run by Cosmetique Active International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the composite score (time frame: from baseline to month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.