Acne VulgarisNCT05457621
Effectiveness and Tolerance of Effaclar Serum in Women With Mandibular Acne
A study testing Effaclar serum in people with Acne Vulgaris, run by Cosmetique Active International at 1 site in France.
Trial summary
The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Effaclar serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2021to 8 Jul 2021
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female subjects aged 20 years or above
- phototype II to IV
- mandibular acne (with or without diffuse acne)
- at baseline (Day0) a AFAST (Adult Female Acne Scoring Tool) score of 1 or 2 in the mandibular area and not over
- 15 non-inflammatory lesions and 5 inflammatory lesions minimum (screening and baseline)
- microcomedones on the mandibular area (visible with Vivacube measurement),
Who cannot join
- men
- female subject pregnant or lactating or who intends to conceive a child during the clinical trial or within one month after the last clinical trial visit
- facial acne without mandibular acne
- still undergoing medical treatment for acne at baseline (D0)
- intensively exposed to UV within the month preceding the baseline visit
- history of any severe disease or current condition (based on subject's interview and/or results of screening physical examination) which, in the opinion of the Investigator would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results (e.g. cancer, immune disorders)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice
About this study
Official title: Evaluation of the Effectiveness and Tolerance of Effaclar Ultra Concentrated Serum in Women With Mandibular Acne for 3 Months (Including 2 Months of Treatment)
The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne.
The aim of the study is to demonstrate the efficacy of the tested product on the appearance of acne lesions in 30 adult women suffering from acne in the mandible following an active anti-acne therapy (systemic or topical). This study includes 2 months of cosmetic treatment with EFFACLAR Ultra Concentrated Serum and one month of followup without any treatment but a moisturizer with a daily UV protection.
Read more
The investigational product has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance.
This product is expected:
- to leave the skin clean and smooth,
- to help unblock pores,
- to exfoliate dead skin cells and help the skin to appear smoother, softer and pore-less,
- to be non-comedogenic.
Read the detailed description
The study is performed in the Centre de Pharmacologie Clinique Appliqué à la Dermatologie (CPCAD), authorized by the French Regional Agency of Health (ARS) to perform biomedical research (Site agreement n°: 2016-04).
This clinical trial protocol and all amendments will be reviewed and approved by an appropriate Independent Ethics Committee (IEC) (Comité de Protection des Personnes (CPP)) located in France. The clinical trial cannot start before CPP approval.
The clinical trial is conducted under the sponsorship of Sponsor in compliance with the applicable international and local regulatory requirements as well as applicable International Council on Harmonisation (ICH) guidelines and in accordance with the Standard Operating Procedures (SOPs) for clinical trial conduct and monitoring from the assigned monitor.
All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk).
Regarding the analysis of efficacy endpoints, quantitative parameters are analyzed using a linear mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point is compared to Baseline using a Dunes adjustment for multiplicity correction. For each fitted model, residual plots will be used to check the model assumptions. If there is an obvious deviation to these assumptions, the analysis is done on the rank-transformed data. Ordinal parameters (GEA) are analyzed using a cumulative link mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point will be compared to Baseline using a Dunnett adjustment for multiplicity correction.
The analysis of cosmeticity/acceptability questionnaire is descriptive only and for the analysis of safety endpoints, no statistical analysis is performed on safety. The data are presented descriptively.
As for the sample size determination, a total of 30 subjects completing the whole study allows to answer to the study objectives.
Clinical Research Associates (CRAs) and other applicable personnel are trained prior to study initiation to familiarize CRAs with the disease, the Standard Operating Procedures (SOP), the protocol and other study specific items.
Regarding the data management, the study data will be collected on an electronic data capture (EDC) set up by the Contract Research Organization (CRO). Computerized edit checks and review processes will be performed on an ongoing basis until all data clarifications are resolved. The data will be exported from a special database to be stored in appropriate format. After all data clarifications are resolved, coding is approved, and subject's evaluability is determined, the database will be locked.
- Conditions
- Acne Vulgaris
- Being tested
- Effaclar serum
- Keywords
- tri-acid complex serum, mandibular acne, microcomedones, maintenance regimen
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effaclar serumOther
Effaclar serum has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance. It acts in particular on imperfections and persistent marks due to acne.
| Study group | Role | What they receive |
|---|---|---|
| Effaclar serum | Experimental | Participants are asked to apply Effaclar serum once daily in the evening on the whole face avoiding contact with eyes for 2 months. Receives: Other: Effaclar serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in GEA (Global Evaluation Acne) score
evaluation of the acne grade by the investigator on a 6-point scale (from 0 Clear. No lesions to 5 Very severe)
Measured: from baseline to Day84
change in Adult Female Acne Scoring Tool (AFAST) score
evaluation of the acne grade by the investigator on a 4-point scale
Measured: from baseline to Day84
change in acne count
lesion count by the investigator: inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (opened/closed comedones) on full face
Measured: from baseline to Day84
change in the seborrhea evaluation
assessment performed by the investigator by visual inspection (gloss and shine aspect), and recorded using a 0-3 grading scale
Measured: from baseline to Day84
Secondary outcomes (6)
change in subject's and Investigator's global assessment of efficacy
opinion given on the global efficacy of the study treatment at each visit (except Day0), using a 7-point scale
Measured: from Day7 to Day84
change in the quantity of sebum
evaluation, with a Sebumeter, of the quantity of sebum excreted to the skin surface. Measurements will be done about 12 h after the last application of any product and 3 h minimum after the last washing of the skin at controlled room temperature (21-25 °C).
Measured: from baseline to Day84
change in the quality of life
Cardiff Acne Disability Index (CADI) questionnaire with 5 questions
Measured: Day0, Day14, Day28, Day56, Day84
change in the global tolerance
evaluation of the tolerance both by the investigator and the patient on a 5-point scale (from 0 None to 4 Very severe)
Measured: from Day7 to Day84
change in the sensitivity assessment by the investigator
assessment of the following signs: erythema, dryness, desquamation by the investigator on a 0-3 score
Measured: from Day48 hours (phone call) to Day84
change in the sensitivity assessment by the participant
assessment of the following symptoms: itching, tingling, burning sensation by the patient on a 0-3 score
Measured: from Day48 hours (phone call) to Day84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start21 Jan 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants attend 7 visits (screening visit, inclusion visit, 4 intermediate visits, final visit) and make a visit by phone call at Day48 hours. They apply the investigational product once daily (evening) for 2 months on the whole face and the accompanying product twice daily for 3 months on the whole face.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Queille-Roussel, Study director, Centre de Pharmacologie Clinique Applique a la Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457621
- Sponsor's protocol ID
- LRP19011-EFFACLAR SERUM
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 14 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Tolerance of Effaclar Ultra Concentrated Serum in Women With Mandibular Acne for 3 Months (Including 2 Months of Treatment)
- ClinicalTrials.gov ID
- NCT05457621
- Acronym / sponsor ID
- LRP19011-EFFACLAR SERUM
- Conditions
- Acne Vulgaris
- Keywords
- tri-acid complex serum, mandibular acne, microcomedones, maintenance regimen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 14 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.
The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne.
The aim of the study is to demonstrate the efficacy of the tested product on the appearance of acne lesions in 30 adult women suffering from acne in the mandible following an active anti-acne therapy (systemic or topical). This study includes 2 months of cosmetic treatment with EFFACLAR Ultra Concentrated Serum and one month of followup without any treatment but a moisturizer with a daily UV protection.
The investigational product has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance.
This product is expected:
- to leave the skin clean and smooth,
- to help unblock pores,
- to exfoliate dead skin cells and help the skin to appear smoother, softer and pore-less,
- to be non-comedogenic.
Detailed description
The study is performed in the Centre de Pharmacologie Clinique Appliqué à la Dermatologie (CPCAD), authorized by the French Regional Agency of Health (ARS) to perform biomedical research (Site agreement n°: 2016-04).
This clinical trial protocol and all amendments will be reviewed and approved by an appropriate Independent Ethics Committee (IEC) (Comité de Protection des Personnes (CPP)) located in France. The clinical trial cannot start before CPP approval.
The clinical trial is conducted under the sponsorship of Sponsor in compliance with the applicable international and local regulatory requirements as well as applicable International Council on Harmonisation (ICH) guidelines and in accordance with the Standard Operating Procedures (SOPs) for clinical trial conduct and monitoring from the assigned monitor.
All statistical tests will be two-sided and at the 5% level of significance. Normality tests will be at the 1% level of significance (Shapiro-Wilk).
Regarding the analysis of efficacy endpoints, quantitative parameters are analyzed using a linear mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point is compared to Baseline using a Dunes adjustment for multiplicity correction. For each fitted model, residual plots will be used to check the model assumptions. If there is an obvious deviation to these assumptions, the analysis is done on the rank-transformed data. Ordinal parameters (GEA) are analyzed using a cumulative link mixed model for repeated measurements with Baseline and Time as fixed effects and Subject as random effect. Each time-point will be compared to Baseline using a Dunnett adjustment for multiplicity correction.
The analysis of cosmeticity/acceptability questionnaire is descriptive only and for the analysis of safety endpoints, no statistical analysis is performed on safety. The data are presented descriptively.
As for the sample size determination, a total of 30 subjects completing the whole study allows to answer to the study objectives.
Clinical Research Associates (CRAs) and other applicable personnel are trained prior to study initiation to familiarize CRAs with the disease, the Standard Operating Procedures (SOP), the protocol and other study specific items.
Regarding the data management, the study data will be collected on an electronic data capture (EDC) set up by the Contract Research Organization (CRO). Computerized edit checks and review processes will be performed on an ongoing basis until all data clarifications are resolved. The data will be exported from a special database to be stored in appropriate format. After all data clarifications are resolved, coding is approved, and subject's evaluability is determined, the database will be locked.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants attend 7 visits (screening visit, inclusion visit, 4 intermediate visits, final visit) and make a visit by phone call at Day48 hours. They apply the investigational product once daily (evening) for 2 months on the whole face and the accompanying product twice daily for 3 months on the whole face.
| Arm | Type | Receives |
|---|---|---|
| Effaclar serum | Experimental | Other: Effaclar serumParticipants are asked to apply Effaclar serum once daily in the evening on the whole face avoiding contact with eyes for 2 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female subjects aged 20 years or above
- phototype II to IV
- mandibular acne (with or without diffuse acne)
- at baseline (Day0) a AFAST (Adult Female Acne Scoring Tool) score of 1 or 2 in the mandibular area and not over
- 15 non-inflammatory lesions and 5 inflammatory lesions minimum (screening and baseline)
Key exclusion criteria (6 listed)
- men
- female subject pregnant or lactating or who intends to conceive a child during the clinical trial or within one month after the last clinical trial visit
- facial acne without mandibular acne
- still undergoing medical treatment for acne at baseline (D0)
- intensively exposed to UV within the month preceding the baseline visit
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 |
|---|---|---|
| Effaclar serumEffaclar serum has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance. It acts in particular on imperfections and persistent marks due to acne. | Other | Effaclar serum |
Primary outcome
change in GEA (Global Evaluation Acne) score
Time frame: from baseline to Day84
evaluation of the acne grade by the investigator on a 6-point scale (from 0 Clear. No lesions to 5 Very severe)
change in Adult Female Acne Scoring Tool (AFAST) score
Time frame: from baseline to Day84
evaluation of the acne grade by the investigator on a 4-point scale
change in acne count
Time frame: from baseline to Day84
lesion count by the investigator: inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (opened/closed comedones) on full face
change in the seborrhea evaluation
Time frame: from baseline to Day84
assessment performed by the investigator by visual inspection (gloss and shine aspect), and recorded using a 0-3 grading scale
6 secondary outcomes
change in subject's and Investigator's global assessment of efficacy
Time frame: from Day7 to Day84
change in the quantity of sebum
Time frame: from baseline to Day84
change in the quality of life
Time frame: Day0, Day14, Day28, Day56, Day84
change in the global tolerance
Time frame: from Day7 to Day84
change in the sensitivity assessment by the investigator
Time frame: from Day48 hours (phone call) to Day84
change in the sensitivity assessment by the participant
Time frame: from Day48 hours (phone call) to Day84
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 14 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.
Catherine Queille-Roussel study director
Centre de Pharmacologie Clinique Applique a la Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effaclar serum in people with Acne Vulgaris, run by Cosmetique Active International at 1 site in France.
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 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 GEA (Global Evaluation Acne) score (time frame: from baseline to Day84). The study lists 4 primary outcomes in all. 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 14 Jul 2022.