Healthy volunteers
Conditions
Interventions
The study will be conducted in a single group of 28 individuals, where the following control areas will be applied to the back of all participants: the saline solution and the following control areas:
Other
Sponsors
Medcin Instituto da Pele Ltda.
Medcin Instituto da Pele Ltda.
Semina Industria e Comercio LTDA
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; Age between 18 and 70 years; Phototypes: II or III according to the adapted scale Fitzpatrick Appendix 1; Skin of the intact test region;
Exclusion criteria
Exclusion criteria: Pregnancy or risk of gestation, lactation when women; Prediction of bathing by sea, pool or bath during the study; Water sports practice during the study; Historical Personal of Atopy; History of sensitization or photosensitization to topical products; Previous history of pathologies worsened or triggered by ultraviolet radiation; Use of anti-inflammatory drugs up to 30 days before selection or immunosuppressants up to 03 months before; Immunosuppression by drugs or active diseases; Endocrinopatias descompensadas; Use of fotossensibilizantes drugs; Active cutaneous pathologies that may interfere with the results of the studies; History or activity of photodermatoses; Dermografismo; Personal or family history of skin cancer; Presence of precursor lesions of cutaneous neoplasia, such as melanocytic nevi and Actinic keratoses; Intense solar exposure in the test area; Use of new medications, cosmetics during the study; participation before in a study with the same product; Relevant clinical history or current evidence of alcohol or other drug abuse; Use of oral or topical treatment with vitamin A acid and or its derivatives up to 1 month before the beginning of the study; Known history or suspicion of intolerance to any ingredient in the study products,test or comparative products; Aesthetic and or dermatological treatment in the body within 03 weeks before selection; Scheduled vaccination during the study period or up to 03 weeks before selection; Other conditions considered by the researcher as reasonable for disqualification of the participation of the study. If yes, it should be described under observation in the clinical form; Employees of Medcin or the sponsoring company involved in the study, or close family member of an employee involved in the study; History of lack of adherence or lack of willingness to adhere to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to demonstrate the absence of irritant potential of the product applied to the skin and using the method of exposure to ultraviolet radiation to perform the reading of scale as recommended by the International Contact Dermatitis Research Group (ICDRG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactSheila Jaime
Semina Industria e Comercio LTDA
Outcome results
None listed