Skin Diseases, Eczematous
Conditions
Interventions
The study is a single-center, single-blind, non-comparative clinical trial to evaluate the photoirritant and photosensitizing potential of the investigational product, KY BIO. A total of 28 participan
Sponsors
Universidade São Francisco
Medcin Instituto da Pele Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; age between 18 and 70 years; phototype II or III (adapted Fitzpatrick scale); intact skin in the application area; agreement to follow the trial procedures; attendance at the clinic on scheduled dates and times for medical evaluations and application and reading of patches; understanding and signing of the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women; use of anti-inflammatory drugs in the last 30 days and immunosuppressive drugs in the last three months; immunosuppression due to medication or active diseases; decompensated endocrinopathies; personal history of atopy; intense sun exposure or tanning sessions up to 15 days before or during the study; anticipated intense sun exposure or tanning sessions during the study; planned sea bathing, swimming pool, or sauna sessions during the study; practice of water sports; dermographism; use of oral or topical vitamin A acid treatments or derivatives up to one week before the study; aesthetic or dermatological treatments on the body within three weeks before the study; scheduled vaccination up to three weeks before or during the study; history of sensitivity, irritation, or photosensitization to topical products; active skin conditions that may interfere with the study results; use of new medications or cosmetics during the study; skin reactivity; congenital or acquired immunodeficiency; significant history or current evidence of alcohol or drug abuse; conditions aggravated by UV radiation; use of photosensitizing drugs; history or activity of photodermatoses; personal or family history of skin cancer; presence of precancerous skin lesions, such as melanocytic nevi and actinic keratoses; lack of adherence to the protocol; employees of Medcin or the sponsoring company involved in the study or close relatives of employees; other conditions considered by the researcher to disqualify participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to confirm the absence of irritation caused by sun exposure, evaluated through dermatological readings based on the International Contact Dermatitis Research Group (ICDRG) scale in study participants. The readings will be conducted after the product application and subsequent exposure to ultraviolet radiation, assessing the parameters of erythema and presence of papules | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactIsabelle Guilhermon Miura
Semina Indústria e Comércio Ltda
Outcome results
None listed