Dermatitis, Contact
Conditions
Interventions
In this single-center, single-blind, non-comparative clinical study, the dermatological safety of a medical device will be evaluated for its photoirritant and photosensitizing potential. A total of 28
Sponsors
Medcin Instituto da Pele LTDA
Medcin Instituto da Pele LTDA
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants must be of both genders; aged between 18 and 70; have Fitzpatrick skin type II or III; intact skin in the product application area. They must agree to follow all study procedures; attend the Center on specified days and times for medical evaluations, applications, and patch readings; sign the Informed Consent Form (ICF), demonstrating full understanding and acceptance of the study conditions
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy/lactation; use of anti-inflammatory drugs in the last 30 days and/or immunosuppressive drugs up to three months before selection; decompensated endocrinopathies; personal history of atopy; intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period; anticipated sea bathing, pool use, or sauna sessions during the study; practice of aquatic sports during the study; dermographism; use of oral or topical treatment with vitamin A acid and/or its derivatives up to one month before the start of the study; aesthetic and/or dermatological treatment on the body within three weeks before selection; scheduled vaccination during the study period or up to three weeks before selection; history of sensitization, irritation, or photosensitization to topical products; active skin conditions (local and/or widespread) that could interfere with study results; skin reactivity; use of new medications during the study; previous participation in studies with the same product; congenital or acquired immunodeficiency; relevant medical history or current evidence of alcohol or drug abuse; known history or suspected intolerance to any ingredient in the study product; history of non-adherence or unwillingness to follow the study protocol; previous history of conditions worsened or triggered by ultraviolet radiation; use of photosensitizing drugs; history or activity of photodermatoses; personal or family history of skin cancer; presence of precursor lesions for skin neoplasia, such as melanocytic nevi and actinic keratosis; use of new medications during the study; other conditions considered by the researcher as reasonable for disqualification from study participation, which must be described as a note in the clinical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the absence of dermatological reaction, including clinical signs of erythema, edema, papules, and other skin manifestations on the International Contact Dermatitis Research Group (ICDRG) scale, after exposure of the investigational product to ultraviolet radiation | — |
Secondary
| Measure | Time frame |
|---|---|
| No additional secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactFrancisco Viana da Silva
Semina Indústria e Comércio Ltda
Outcome results
None listed