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Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.
Evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. Comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants of both sexes, 18 - 70 y | Active Comparator | Participants of both sexes, 18 - 70 y, who have recent scars. |
|
| Exp.: Participants of both sexes, 18 - 70 y | Experimental | Participants of both sexes, 18 - 70 y, with recent scars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scar gel | Device | Health care product (scar gel) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical and perceived efficacy | Evaluate the prevention of hypertrophic scars after 90 days of continuous use of the investigational product. The dermatologist will perform assessments of the clinical parameters using the POSAS scale. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived efficacy | To compare the treatments of the benchmark product versus the investigational product in improving the appearance of scars, discomfort, skin hydration, itching and normalization of scar pigmentation, after 90 days of use, through a questionnaire on perceived efficacy. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flávia A. S. Addor | Contact | (55) 11 3683-5366 | contato@medcinpesquisa.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele Ltda | Not yet recruiting | Osasco | São Paulo | Brazil |
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Clinical trial, double arm, double blind, randomized
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| Scar gel comparator |
| Device |
Health care product (Scar gel comparator) |
|
| MEDCIN | Recruiting | Osasco | Brazil |
|
| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| D007627 | Keloid |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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