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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
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:
Calculated parameter
â–ª Total number of lesions (inflammatory lesions + total lesions + other lesions).
Calculated parameter
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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):
EFFACLAR DUO+M CREAM application |
|
| 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):
EFFACLAR DUO+M CREAM application |
|
| 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
EFFACLAR DUO+M CREAM application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and Cosmetic acceptability through Self-assessment questionnaire | To collect the participants' opinion and their perceptions regarding product efficacy | 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 |
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Inclusion Criteria:
All phototypes - with at least 5 subjects of each phototype per assessment area:
III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
III-IV / 25 phototypes V-VI. Minimum 5 subjects per phototype):
Four weeks before study starts subject should:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Thais Pontes, Dr | ARTHA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARTHA | Rio de Janeiro | Centro Rj | 20070-900 | Brazil |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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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).
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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:
Illustrative standardized images with Colorface device |
| Day 0, Day 28 and Day 42 |
| Tolerance | Safety feedback and report of adverse events | Day 0, Day 28 and Day 42 |