AcneNCT06786442

Clinical Efficacy Evaluation of a Skincare Product for Acne Face, Upper Chest and Back Used by Multiphototype Population Under Dermatological Control

A study testing EFFACLAR DUO+M CREAM in people with Acne, run by Cosmetique Active International at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Acne
What is being tested?: EFFACLAR DUO+M CREAM
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteBrazil
Study dates: 1 Nov 2023to 26 Jan 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 16 to 45 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

All phototypes - with at least 5 subjects of each phototype per assessment area:
I, II: n=at least 25
III, IV: n= at least 25
V, VI: n=at least 25 All skin sensitivity (sensitive or non-sensitive); All skin types (dry, normal, combination or oily); Not presenting severe acne; All ethnicities; At least 75 subjects prone to acne of the face (25 phototypes I-II / 25 phototypes
III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
Presenting at least 10 retentional lesions on the assessment zone

Show all 20Show fewer

Presenting at least 5 inflammatory lesions on the assessment zone
Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). At least 75 subjects prone to acne of the back (25 phototypes I-II / 25 phototypes
III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
Presenting at least 10 retentional lesions on the assessment zone
Presenting at least 5 inflammatory lesions on the assessment zone
Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). At least 75 subjects prone to acne of the upper chest (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
Presenting at least 10 retentional lesions on the assessment zone
Presenting at least 5 inflammatory lesions on the assessment zone
If possible (non-mandatory for this area): Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). Accepting to use their usual neutral sunscreen SPF (30 mini) daily and accepting not to expose themselves intensively to the sun and to use protection (hat and UV clothes, for example); Not presenting an excessive hair on the assessment areas; Not presenting tattoo in the assessment area that could interfere with the evaluations and with the possibility of exploiting the photographs; Able to apply the product to the whole application area;
Four weeks before study starts subject should:
Not use any anti-acne/anti-sebum product;
Use neutral cleanser;
Use neutral sunscreen (minimum SPF 30);
Not have exposed themselves intensively to the sun. Subjects in good general and mental health in the opinion of the investigator; Subjects demonstrating understanding of the study procedures, restrictions, schedule, and willingness to participate as evidenced by voluntary written informed consent. Subjects under 18 years old willing to participate will provide their written consent as well as their legal responsible.

Who cannot join

Pregnant or breastfeeding women; Any history of significant dermatological diseases or medical conditions may affect the clinical evaluation of the study product; Subjects currently using any medication, which in the opinion of the investigator, may affect the clinical evaluation of the study product; Previous history of atopy, allergic reactions, irritation, or intense discomfort feelings to similar products to the tested one; Visible sun-tanned skin; Subjects presenting excessive hair in the assessed areas (shaving of upper chest will only be accepted if already in the subject's usual routine for at least the last 3 months before inclusion visit); Having introduced new products within 4 weeks prior to the inclusion visit; Having performed any aesthetic procedures in the evaluated areas 12 months before study starts; Using any cosmetic products that may influence sebum control and/or claiming an action in the acne lesion or skin imperfections in the last month before study starts;
Previous aesthetic cares in the following periods before D0:
Aesthetic procedures (chemical or mechanical peeling, dermabrasion, laser, pulsed light, etc.) on the evaluation areas - 12 months
Oral retinoid-based treatment and injections on the evaluation areas- 6 months;
Beginning, change or discontinuation of hormonal treatment (oestroprogesteron, cyproteron acetate, androgenic…) - 3 months;
Cure of minerals or vitamin supplements (such as zinc, vitamin A, vitamin E…) - 3 months;

Show all 12Show fewer

Anti-acne and anti-seborrheic medical treatment (oral and topical), topical retinoid treatement and depigmenting/whitening product use - 2 months;
Antibiotic and/or anti-inflammatory treatment (oral), aesthetic care at home or in a beauty salon (such as exfoliating scrub, mask) on the evaluation areas - 1 month;
Exposure to direct sunlight or artificial UV, and self-tanning product on the evaluation areas - 1 month;
Cosmetic products designated to regulate sebum secretion and/or acne - 1 month;
Cosmetic products (skincare and/or make-up and/or shampoo) other than usual cleanser on the evaluation areas - 24 hours;
Last shaving performed on the evaluation areas - 24 hours (men only); Having undergone aesthetics surgery on the evaluation areas; Permanent makeup: only on the lips and eyes are allowed, but without any retouching during the study; Having applied cosmetic products (skincare, make-up and/or cleanser) on the evaluation areas and/or shampoo and/or hairspray at day of inclusion visit;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

ARTHA
Rio de Janeiro, Centro Rj, 20070-900

Other trials in Brazil

About this study

The present aims to confirm, under normal conditions of use, the IP's clinical efficacy in controlling acne on the face, upper chest, and back after 28 and 42 days of product use, as well as illustrate its efficacy through standardized pictures. In addition, it is expected to assess the sensations of discomfort reported by participants at cutaneous levels, taking into consideration the product use guidelines determined by the manufacturer, and the self-perceived efficacy by participants immediately after the first application, after 7, 28, 42 days using the IP

Read the detailed description

In accordance with ANVISA's definition on RDC 07 of 2015, personal hygiene products, cosmetics, and perfume are preparations composed of natural or synthetic substances, for external use on the various parts of the body such as skin, hair, nails, lips, external genital, teeth and mucous membranes of the oral cavity, with the exclusive or main purpose of cleaning and perfuming them, changing their appearance, correcting body odors, protecting and/or keeping them in good condition. It is of great importance that companies conduct clinical studies of their products so that consumers have maximum safety with the lowest risk of use. After confirming the evidence of safety of use by humans, the manufacturing company must submit the results obtained to ANVISA (whether the company intends to sell it in Brazil), as well as establishing label warnings and consumer service guidelines based on the information obtained. According to Helsinki Declaration and Brazilian legislation, any research involving human beings must comply with ethical premises. The purpose of them is to protect individuals' integrity, dignity, well-being, rights, and confidentiality. Therefore, studies involving personal care products, cosmetics and perfumes in safety investigation phase (i.e. investigational products) must follow the recommendations of Good Clinical Practices (GCP).

STATISTICAL ANALYSIS PLAN For each study assessment area (face, upper chest, and back), four statistical analysis will be conducted: one global analysis and one analysis per phototype cluster (I-II, III-IV, and V-VI). A total of 12 statistical analysis will be performed.

Parameters to be Analyzed:

Number of papules;
Number of pustules;
Number of nodules;
Number of blackheads;
Number of microcysts;
Number of excoriated lesions without inflammation;
Number of red acne residual marks;
Number of brown acne residual marks;
Number of inflammatory lesions (papules + pustules + nodules). Calculated parameter
Number of retentional lesions (blackhead + microcysts). Calculated parameter
Number of acne residual marks (red acne residual marks + brown acne residual marks). Calculated parameter
Number of other lesions (excoriated lesions without inflammation + residual marks).

Calculated parameter

▪ Total number of lesions (inflammatory lesions + total lesions + other lesions).

Calculated parameter

Conditions: Acne
Being tested: EFFACLAR DUO+M CREAM
Keywords: acne, truncal acne
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 DUO+M CREAMOther
twice a day: morning and evening. Subjects should be able to self-apply the product on all assessment areas (face, upper chest, and back)

Study groups in NCT06786442
Study group	Role	What they receive
FACE ACNE GROUP	Experimental	At least 75 subjects prone to acne of the face (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype): * Presenting at least 10 retentional lesions on the assessment zone * Presenting at least 5 inflammatory lesions on the assessment zone * Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). EFFACLAR DUO+M CREAM application Receives: Other: EFFACLAR DUO+M CREAM
BACK ACNE GROUP	Experimental	At least 75 subjects prone to acne of the back (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype): * Presenting at least 10 retentional lesions on the assessment zone * Presenting at least 5 inflammatory lesions on the assessment zone * Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). EFFACLAR DUO+M CREAM application Receives: Other: EFFACLAR DUO+M CREAM
UPPER CHEST ACNE GROUP	Experimental	At least 75 subjects prone to acne of the upper chest (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype): Presenting at least 10 retentional lesions on the assessment zone * Presenting at least 5 inflammatory lesions on the assessment zone * If possible (non-mandatory for this area): Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). EFFACLAR DUO+M CREAM application Receives: Other: EFFACLAR DUO+M CREAM

What is being measured

The primary outcome is the main question the study is designed to answer.

Acne lesion and acne residual brown and red marks count
The acne count will be performed based on the "LesionsCount Guidelines v 0.1" provided by the sponsor and acquired images will confirm the lesion location and accountability for all three areas. To assess the IP efficacy, at D0, D28 and D42, the dermatologist will perform an acne lesion and residual marks count by type as follows: inflammatory lesions (nodules, pustules and papules, including recently excoriated papules), non-inflammatory/retentional lesions (open comedones/blackheads, closed comedones/microcysts) and other lesions (excoriated lesions without inflammation and red acne residual marks and brown acne residual marks), for each assessment area (face, upper chest and back).
Measured: Day 0, Day 28 and Day 42

Secondary outcomes (3)

Efficacy and Cosmetic acceptability through Self-assessment questionnaire
To collect the participants' opinion and their perceptions regarding product efficacy
Measured: immediately after the first application (Day 0 T immediately), Day 7, Day 28 of product use and day 42 of product use
Illustrative photographies of tested areas
Illustrative standardized images with Colorface device
Measured: Day 0, Day 28 and Day 42
Tolerance
Safety feedback and report of adverse events
Measured: Day 0, Day 28 and Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202326 Jan 2024

First posted22 Jan 2025
Study start1 Nov 2023
Primary completion5 Jan 2024
Study completion26 Jan 2024

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: Randomised
Intervention model: Parallel groups
Model description: all the three areas (face, upper chest, and back) need to conclude the study with a minimum of 75 valid cases (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Mini 5 subjects per phototype).
Masking: Single blind
Who is masked: Participant
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06786442
Sponsor's protocol ID: EV2309-0768 ZONIFICATION LABO
Status last verified: Jan 2025
First submitted: 7 Jan 2025
Last updated: 22 Jan 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy Evaluation of a Skincare Product for Acne Face, Upper Chest and Back Used by Multiphototype Population Under Dermatological Control
ClinicalTrials.gov ID: NCT06786442
Acronym / sponsor ID: EV2309-0768 ZONIFICATION LABO
Conditions: Acne
Keywords: acne, truncal acne
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Cosmetique Active InternationalIndustry (pharma, biotech, devices)
Study start: 1 Nov 2023 (actual)
Primary completion: 5 Jan 2024 (actual)
Study completion: 26 Jan 2024 (actual)
First posted: 22 Jan 2025 (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.

Detailed description

Parameters to be Analyzed:

Number of papules;
Number of pustules;
Number of nodules;
Number of blackheads;
Number of microcysts;
Number of excoriated lesions without inflammation;
Number of red acne residual marks;
Number of brown acne residual marks;
Number of inflammatory lesions (papules + pustules + nodules). Calculated parameter
Number of retentional lesions (blackhead + microcysts). Calculated parameter
Number of acne residual marks (red acne residual marks + brown acne residual marks). Calculated parameter
Number of other lesions (excoriated lesions without inflammation + residual marks).

Calculated parameter

▪ Total number of lesions (inflammatory lesions + total lesions + other lesions).

Calculated parameter

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: all the three areas (face, upper chest, and back) need to conclude the study with a minimum of 75 valid cases (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Mini 5 subjects per phototype).

Arm	Type	Receives
FACE ACNE GROUP	Experimental	Other: EFFACLAR DUO+M CREAMAt least 75 subjects prone to acne of the face (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype): * Presenting at least 10 retentional lesions on the assessment zone * Presenting at least 5 inflammatory lesions on the assessment zone * Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). EFFACLAR DUO+M CREAM application
BACK ACNE GROUP	Experimental	Other: EFFACLAR DUO+M CREAMAt least 75 subjects prone to acne of the back (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype): * Presenting at least 10 retentional lesions on the assessment zone * Presenting at least 5 inflammatory lesions on the assessment zone * Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). EFFACLAR DUO+M CREAM application
UPPER CHEST ACNE GROUP	Experimental	Other: EFFACLAR DUO+M CREAMAt least 75 subjects prone to acne of the upper chest (25 phototypes I-II / 25 phototypes III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype): Presenting at least 10 retentional lesions on the assessment zone * Presenting at least 5 inflammatory lesions on the assessment zone * If possible (non-mandatory for this area): Presenting at least 1 brown and/or red residual acne mark(s) on the assessment zone (the acne origin of these marks must be checked by the dermatologist by questioning the subject). EFFACLAR DUO+M CREAM application

Who may qualify

Ages: 16 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (20 listed)

I, II: n=at least 25
III, IV: n= at least 25
V, VI: n=at least 25 All skin sensitivity (sensitive or non-sensitive); All skin types (dry, normal, combination or oily); Not presenting severe acne; All ethnicities; At least 75 subjects prone to acne of the face (25 phototypes I-II / 25 phototypes
Presenting at least 10 retentional lesions on the assessment zone
Presenting at least 5 inflammatory lesions on the assessment zone

Key exclusion criteria (12 listed)

Pregnant or breastfeeding women; Any history of significant dermatological diseases or medical conditions may affect the clinical evaluation of the study product; Subjects currently using any medication, which in the opinion of the investigator, may affect the clinical evaluation of the study product; Previous history of atopy, allergic reactions, irritation, or intense discomfort feelings to similar products to the tested one; Visible sun-tanned skin; Subjects presenting excessive hair in the assessed areas (shaving of upper chest will only be accepted if already in the subject's usual routine for at least the last 3 months before inclusion visit); Having introduced new products within 4 weeks prior to the inclusion visit; Having performed any aesthetic procedures in the evaluated areas 12 months before study starts; Using any cosmetic products that may influence sebum control and/or claiming an action in the acne lesion or skin imperfections in the last month before study starts;
Aesthetic procedures (chemical or mechanical peeling, dermabrasion, laser, pulsed light, etc.) on the evaluation areas - 12 months
Oral retinoid-based treatment and injections on the evaluation areas- 6 months;
Beginning, change or discontinuation of hormonal treatment (oestroprogesteron, cyproteron acetate, androgenic…) - 3 months;
Cure of minerals or vitamin supplements (such as zinc, vitamin A, vitamin E…) - 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
EFFACLAR DUO+M CREAMtwice a day: morning and evening. Subjects should be able to self-apply the product on all assessment areas (face, upper chest, and back)	Other	BACK ACNE GROUP, FACE ACNE GROUP, UPPER CHEST ACNE GROUP

Primary outcome

Acne lesion and acne residual brown and red marks count
Time frame: Day 0, Day 28 and Day 42
The acne count will be performed based on the "LesionsCount Guidelines v 0.1" provided by the sponsor and acquired images will confirm the lesion location and accountability for all three areas. To assess the IP efficacy, at D0, D28 and D42, the dermatologist will perform an acne lesion and residual marks count by type as follows: inflammatory lesions (nodules, pustules and papules, including recently excoriated papules), non-inflammatory/retentional lesions (open comedones/blackheads, closed comedones/microcysts) and other lesions (excoriated lesions without inflammation and red acne residual marks and brown acne residual marks), for each assessment area (face, upper chest and back).

3 secondary outcomes

Efficacy and Cosmetic acceptability through Self-assessment questionnaire
Time frame: immediately after the first application (Day 0 T immediately), Day 7, Day 28 of product use and day 42 of product use
Illustrative photographies of tested areas
Time frame: Day 0, Day 28 and Day 42
Tolerance
Time frame: Day 0, Day 28 and Day 42

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 Jan 2025.
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. This study is not recruiting at the moment.

Thais Pontes, Dr principal investigator

ARTHA

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 DUO+M CREAM 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 20 inclusion and 12 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 Jan 2025. 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?

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?

Acne lesion and acne residual brown and red marks count (time frame: Day 0, Day 28 and Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06786442.

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 Jan 2025.