AcneNCT06716398
A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase
A study testing Test product and Comparator product in people with Acne, run by Pierre Fabre Dermo Cosmetique at 1 site in Brazil.
Trial summary
In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Acne
- What is being tested?
- Test product and Comparator product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jul 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or Female aged between 14 and 24 years (included)
- Subject with facial acne with score index severity IGA = 2 or 3, assessed on a scale ranged from 0 to 4.
- Subject for whom a prescription of 12 weeks of a reference topical medical treatment is required from the day of the inclusion visit, for mild to moderate face acne
Who cannot join
- Criteria related to the disease:
- Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
- Acne conglobata, Acne fulminans, nodulocystic acne or acneiform eruptions, according to investigator's assessment
- Other type of pigmentation disorder than acne-related PIH liable to interfere with the study assessments according to the investigator
- Criteria related to treatments and/or products:
- Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
UNIFESP
São Paulo, 04024-002
Edileia BAGATIN, MD,PhD, +55 11 5579-2581, nucleodepesquisa@huhsp.org.br
Edileia BAGATIN, MD,PhD
About this study
Official title: A Randomized Investigator-blinded Comparative Study to Assess the Efficacy of the Cosmetic Care Product RV4133C - Formula JT2559 in Subjects With Facial Acne, During a 3-month-associated-treatment Phase Followed by a 3-month-maintenance Phase
In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.
- Conditions
- Acne
- Being tested
- Test product, Comparator product
- Keywords
- acne, face, young adults, teenagers, treatment phase, maintenance
- 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.
Test productOther
Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.
Comparator productOther
Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Other: Test product |
| Comparative group | Placebo comparator | Not described Receives: Other: Comparator product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of number of total acne lesions on the face
Number of total acne lesions by counting according to the Lucky method performed by the investigator
Measured: Assessment after 24 weeks of use
Secondary outcomes (12)
Investigator's global assessment (IGA)
Assessed by the investigator on the face on a 5-point scale ranged from 0 (clear) to 4 (severe)
Measured: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne lesions counting
Number of all type of acne lesions by counting according to subject's photographs analysis using acne Artificial Intelligence
Measured: Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne QoL questionnaire
Assessed by the subject via a specific questionnaire of 19 questions
Measured: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Subject's Global change Assessment (SGA)
Assessed by the subject via a 7-point scale: SGA of acne severity
Measured: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Hyperpigmentation (PIH) lesions counting
Number of PIH lesions by counting according to the Lucky method performed by the investigator
Measured: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Erythema (PIE) lesions counting
Number of PIE lesions by counting according to the Lucky method performed by the investigator
Measured: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Subject's Global change Assessment (SGA) of post inflammatory lesions
Assessed by the subject via a 7-point scale: SGA of post inflammatory lesions (PIH and PIE)
Measured: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne worsening/ relapse
Number and percentage of acne worsening/ relapse, defined by the investigator by the necessity to change the topical medical treatment and/ or to introduce an oral medical treatment for facial acne
Measured: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Time to relapse
The time to first acne relapse will be calculated from the date of Visit 3 (start of maintenance phase) to the date of failure (acne relapse).
Measured: Assessment after 4 weeks and 12 weeks of use, without reference medical treatment
Global tolerance assessed by the investigator on a 5-point scale
Measured: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Compliance of the subjects to the product RV4133C
The subject will report his/her compliance in a subject's diary
Measured: Through study completion, 6 months
Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient
A questionnaire with a scale from 0 to 10 responding to statements about the effect of the product (0=not at all agree, 10=completely agree).
Measured: Assessed after 4 weeks of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start3 Jul 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716398
- Sponsor's protocol ID
- RV4133C20230380
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Investigator-blinded Comparative Study to Assess the Efficacy of the Cosmetic Care Product RV4133C - Formula JT2559 in Subjects With Facial Acne, During a 3-month-associated-treatment Phase Followed by a 3-month-maintenance Phase
- ClinicalTrials.gov ID
- NCT06716398
- Acronym / sponsor ID
- RV4133C20230380
- Conditions
- Acne
- Keywords
- acne, face, young adults, teenagers, treatment phase, maintenance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 4 Dec 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.
In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Test product |
| Comparative group | Placebo comparator | Other: Comparator product |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or Female aged between 14 and 24 years (included)
- Subject with facial acne with score index severity IGA = 2 or 3, assessed on a scale ranged from 0 to 4.
- Subject for whom a prescription of 12 weeks of a reference topical medical treatment is required from the day of the inclusion visit, for mild to moderate face acne
Key exclusion criteria (6 listed)
- Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
- Acne conglobata, Acne fulminans, nodulocystic acne or acneiform eruptions, according to investigator's assessment
- Other type of pigmentation disorder than acne-related PIH liable to interfere with the study assessments according to the investigator
- Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational 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 |
|---|---|---|
| Test productTwice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face. | Other | Test Group |
| Comparator productTwice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face. | Other | Comparative group |
Primary outcome
Assessment of number of total acne lesions on the face
Time frame: Assessment after 24 weeks of use
Number of total acne lesions by counting according to the Lucky method performed by the investigator
12 secondary outcomes
Investigator's global assessment (IGA)
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne lesions counting
Time frame: Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne QoL questionnaire
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Subject's Global change Assessment (SGA)
Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Hyperpigmentation (PIH) lesions counting
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Post-Inflammatory Erythema (PIE) lesions counting
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Subject's Global change Assessment (SGA) of post inflammatory lesions
Time frame: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Acne worsening/ relapse
Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Time to relapse
Time frame: Assessment after 4 weeks and 12 weeks of use, without reference medical treatment
Global tolerance assessed by the investigator on a 5-point scale
Time frame: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use
Compliance of the subjects to the product RV4133C
Time frame: Through study completion, 6 months
Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient
Time frame: Assessed after 4 weeks of use
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product and Comparator product in people with Acne, run by Pierre Fabre Dermo Cosmetique 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 3 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: looking for participants now, as of the sponsor's last update on 4 Dec 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeline Bacquey (+33562877753, adeline.bacquey@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of number of total acne lesions on the face (time frame: Assessment after 24 weeks of use). 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 4 Dec 2024.