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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acneic participants group | Other | subjects with mild to moderate facial and truncal acne |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acneic participants group | Other | Application of Effaclar Duo+M to the face and trunk twice daily (morning and evening) after washing with the cleansing gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to Day168 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | from baseline to Day168 |
| Evaluation of the degree of severity of acne on the trunk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Nascimento | Contact | +55 21 98726-2046 | a.nascimento@cidp-cro.com |
| Name | Affiliation | Role |
|---|---|---|
| Renato Moura | Centre International de Développement Pharmaceutique (CIDP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDP Brasil | Recruiting | Rio de Janeiro | Brazil |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D019066 | Facies |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Evaluation performed thanks to the Investigator Global Assessment (IGA) scale on a 6-point score: from 0 (Absent) to 5 (Very serious). |
| from baseline to Day168 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |