Diaper Rash
Conditions
Interventions
Clinical, single-blind, comparative study. The experimental product is a clear barrier diaper rash treatment gel. For this research, up to 55 participants aged between 18 and 70 years of phototype I t
Sponsors
Medcin Instituto da Pele Ltda
Megalabs Farmacêutica S.A.
Medcin Instituto da Pele Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes aged 18 to 70 years; intact skin in the region of application; agreement to follow trial procedures and to report to the clinic on designated days and times for medical assessments and application and reading of pads; understanding, consent and signature of the Free and Informed Consent Term (TCLE); phototype: I, II, III and IV (for the phototest test, only phototypes II and III will be considered)
Exclusion criteria
Exclusion criteria: For the HRIPT trial and phototest: Participants who have been diagnosed with COVID 19 within the last 4 weeks or who are experiencing symptoms such as fever, dry cough, tiredness, body aches or other discomforts; pregnancy or risk of pregnancy and/or lactation (when women); use of anti-inflammatory drugs 30 days and/or immunosuppressants for up to three months before selection; immunosuppression by drugs or active diseases; 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 intense exposure to sunlight or tanning sessions during the study period; prediction of sea bathing, swimming pool or sauna during the study; practice of water sports during the study; dermographism; use of oral or topical treatment with vitamin A acid and/or its derivatives up to 1 week before the start of the study; aesthetic and/or dermatological treatment on the body within 03 weeks before selection; scheduled vaccination during the study period or up to 03 weeks before selection; history of sensitization, irritation, or photosensitivity to topical products; active skin pathologies (local and/or disseminated) that may interfere with the study results; skin reactivity; use of new drugs/cosmetics during the study; previous participation in studies with the same product; congenital or acquired immunodeficiency; relevant medical history or current evidence of alcohol or other drug abuse; history of known or suspected intolerance to any ingredient of the study products (test or comparative product); history of non-compliance or unwillingness to adhere to the study protocol; employees of Medcin or the sponsoring company involved in the study, or a close family member of an employee involved in the study; other conditions considered by the researcher as reasonable for disqualification from participation in the study. If yes, it should be described in observation in the clinical record. Only for the phototest test: previous history of pathologies aggravated 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 of skin cancer, such as melanocytic nevi and actinic keratoses; use of new drugs/cosmetics during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of primary dermal irritation reactions of the investigational product under normal conditions (HRITP) evaluated by patch test, with controlled area of application and quantity. The evaluations of irritation reactions will be carried out by the Scale of the International Investigator Group of Contact Dermatitis - ICDRG. Evaluations of Primary Dermal Irritability reactions will be performed 2 and 5 days after application. The results will be presented according to Spiewak's adapted reading scale, demonstrating whether or not there was a positive response to irritability, according to the product category, form of use and number of participants who showed positivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absence of cumulative irritation reactions of the investigational product under normal conditions (HRITP) evaluated by patch test, with controlled area of application and quantity. The evaluations of irritation reactions will be carried out by the Scale of the International Investigator Group of Contact Dermatitis - ICDRG. Assessments of Accumulated Dermal Irritability reactions will be performed after new applications 3 times a week for 3 consecutive weeks during the induction period. The results will be presented according to Spiewak's adapted reading scale, demonstrating whether or not there was a positive response to irritability, according to the product category, form of use and number of participants who showed positivity.;Absence of allergic reactions (dermal sensitization) of the investigational product under normal conditions (HRITP) evaluated by patch test, with controlled area of application and quantity. The evaluations of irritation reactions will be carried out by the Scale of the International Investigator Group of Contact Dermatitis - ICDRG. The evaluations of Dermal Sensitization reactions (challenge) will be evaluated after 2 weeks of rest from product applications and new application of the product in virgin area. The results will be presented according to Spiewak's adapted reading scale, demonstrating whether or not there was a positive response to sensitization, according to the product category, form of use and number of participants who showed positivity.;Absence of photoirritation reactions of the investigational product when exposed to sunlight (Phototest) evaluated by patch test, with controlled area of application and quantity. The assessments of photoirritation and photosensitivity reactions will be carried out using the Scale of the International Investigator Group on Contact Dermatitis – ICDRG. Evaluations of Dermal Photoirritation reactions will be performed 24 and 48 hours after application, the patchs will be removed, the region wil | — |
Countries
Brazil
Contacts
Public ContactFlávia Addor
Medcin Instituto da Pele Ltda
Outcome results
None listed