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

NCT06786442 | Completed DMC

• 1 other identifier: EV2309-0768 ZONIFICATION LABO
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne

Keywords

acne; truncal acne

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 0, Day 28 and Day 42

Secondary Outcomes (3)

• Efficacy and Cosmetic acceptability through Self-assessment questionnaire

  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

  Day 0, Day 28 and Day 42

• Tolerance

  Day 0, Day 28 and Day 42

Study Arms (3)

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

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

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

Other: EFFACLAR DUO+M CREAM

Interventions

EFFACLAR DUO+M CREAM OTHER

twice a day: morning and evening. Subjects should be able to self-apply the product on all assessment areas (face, upper chest, and back)

BACK ACNE GROUP; FACE ACNE GROUP; UPPER CHEST ACNE GROUP

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

ARTHA

Rio de Janeiro, Centro Rj, 20070-900, Brazil

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Thais Pontes, Dr

  ARTHA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be identified by Screening Number (TXXX) and Inclusion/Randomization Number (R-00XX) at the very first study visit to maintain the confidentiality of their data. One hundred and thirty (130) subjects will be included to complete the study with at least seventy-five (75) valid cases for each assessment area, and among them: * 25 subjects with phototypes I and II for each assessment area; * 25 subjects with phototypes III and IV for each assessment area; * 25 subjects with phototypes V and VI for each assessment area.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 22, 2025
• Study Start: November 1, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 26, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)