AcneNCT06463925
Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk
A study testing acneic participants group in people with Acne, run by Cosmetique Active International at 1 site in Brazil.
Trial summary
This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- acneic participants group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Dec 2023to Sep 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- phototype I to VI
- mild to moderate acne on the face and trunk
Who cannot join
- cutaneous pathology on the studied zone other than acne
- topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
CIDP Brasil
Rio de Janeiro
Alessandro Nascimento, +55 21 98726-2046, a.nascimento@cidp-cro.com
About this study
Official title: Evaluation of Effaclar Duo+M on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk (Back and Chest)
This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.
Read the detailed description
The study will be conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil3, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice.
Statistical methodology:
Quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables are summarized in the form of counts and percentages.
Significance level:
The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.
- Conditions
- Acne
- Being tested
- acneic participants group
- Keywords
- facial and truncal acne, Effaclar Duo+M, acne lesions
- Medical subject headings
- Acne Vulgaris, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acneic participants groupOther
Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel.
| Study group | Role | What they receive |
|---|---|---|
| acneic participants group | Other | subjects with mild to moderate facial and truncal acne Receives: Other: acneic participants group |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy on total acne lesion count on face and trunk
The counting is performed by region (back, chest, face, total) and type of lesion (post-inflammatory hyperpigmentation, post-inflammatory erythema, scars, pustules, nodules, papules, closed comedones, open comedones.
Measured: from baseline to Day168
Secondary outcomes (2)
Evaluation of the degree of severity of acne on the face
Evaluation performed thanks to the Global Evaluation Acne (GEA) scale on a 6-point score: from 0 (Clean. No lesions) to 5 (Very severe).
Measured: from baseline to Day168
Evaluation of the degree of severity of acne on the trunk
Evaluation performed thanks to the Investigator Global Assessment (IGA) scale on a 6-point score: from 0 (Absent) to 5 (Very serious).
Measured: from baseline to Day168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start7 Dec 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renato Moura, Principal investigator, Centre International de Développement Pharmaceutique (CIDP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463925
- Sponsor's protocol ID
- LRP23014-2223CBCL059 Effaclar
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effaclar Duo+M on Inflammatory and Non-Inflammatory Lesions in Subjects With Mild to Moderate Acne on Face and Trunk (Back and Chest)
- ClinicalTrials.gov ID
- NCT06463925
- Acronym / sponsor ID
- LRP23014-2223CBCL059 Effaclar
- Conditions
- Acne
- Keywords
- facial and truncal acne, Effaclar Duo+M, acne lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Jun 2024 (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.
This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.
Detailed description
The study will be conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil3, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice.
Statistical methodology:
Quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables are summarized in the form of counts and percentages.
Significance level:
The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acneic participants group | Other | Other: acneic participants groupsubjects with mild to moderate facial and truncal acne |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- phototype I to VI
- mild to moderate acne on the face and trunk
Key exclusion criteria (2 listed)
- cutaneous pathology on the studied zone other than acne
- topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products
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 |
|---|---|---|
| acneic participants groupApplication of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel. | Other | acneic participants group |
Primary outcome
efficacy on total acne lesion count on face and trunk
Time frame: from baseline to Day168
The counting is performed by region (back, chest, face, total) and type of lesion (post-inflammatory hyperpigmentation, post-inflammatory erythema, scars, pustules, nodules, papules, closed comedones, open comedones.
2 secondary outcomes
Evaluation of the degree of severity of acne on the face
Time frame: from baseline to Day168
Evaluation of the degree of severity of acne on the trunk
Time frame: from baseline to Day168
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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.
Renato Moura principal investigator
Centre International de Développement Pharmaceutique (CIDP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acneic participants group in people with Acne, run by Cosmetique Active International at 1 site in Brazil.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Nascimento (+55 21 98726-2046, a.nascimento@cidp-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy on total acne lesion count on face and trunk (time frame: from baseline to Day168). 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 18 Jun 2024.