Diaper Rash
Conditions
Interventions
Unicentric, single blind, comparative clinical study to evaluate the efficacy of the investigational product in the treatment of diaper rash through clinical and subjective evaluations. The experiment
Sponsors
Medcin Instituto da Pele Ltda
Megalabs Farmacêutica S.A.
Medcin Instituto da Pele Ltda
Eligibility
Age
3 Months to 3 Years
Inclusion criteria
Inclusion criteria: Participants of both sexes; age between 3 months and 2 years and 11 months; diaper wearers; with irritant diaper dermatitis; with mild to moderate intertrigo, mild or clear erythema, without maceration, erosion or signs of infection in the area where the diaper is used; at least one parent or legal responsible willing to follow the trial procedures and attend the clinic on the days and times determined for applications and/or evaluations; at least one parent or legal responsible of the participants must understand, agree and sign the Informed Consent Form (TCLE)
Exclusion criteria
Exclusion criteria: Participants and parents or legal responsible who have been diagnosed with COVID-19 in the last 4 weeks or who are experiencing symptoms such as fever, dry cough, tiredness, body aches or other discomforts; use of anti-inflammatory/immunosuppressive/antihistamine drugs up to 3 weeks before selection; atopic or allergic history to cosmetic products; immunosuppression by drugs or active diseases; decompensated endocrinopathies; known history of or suspected intolerance to products in the same category; intense sun exposure up to 15 days before the assessment; aesthetic or dermatological treatment up to 4 weeks before the evaluation; children of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirm the safety of the products under normal conditions of use, the absence of risk of irritation and capture feelings of discomfort in the studied population, under criteria of dermatological and pediatric evaluations. The occurrence and degree of erythema, edema, desquamation and vesiculation will be evaluated using a 4-point scale, 0 being absent and 3 being intense. The results will be evaluated using the t-student or Wilcoxon test, to compare experimental times and to compare treatments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the clinical efficacy of the products in the treatment of diaper rash through dermatological and pediatric evaluations before (D0) and after 07 (D7) and 21 (D21) days of continuous use of the products. Dermatological and pediatric evaluations will be performed at the initial visit (D0), after 7 days (D7) and final visit (D21). The extent of diaper irritant dermatitis, the intensity of the rash, the intensity of the erythema and skin hydration will be evaluated, with the application of a 5-point scale, 1 being very intense and 5 absent, as well as an evaluation of the investigator's perception if the product proved to be effective in improving the signs of diaper rash, if the product would be recommended and approved for use on diaper rash skin. The results will be evaluated using the t-student or Wilcoxon test, to compare experimental times and to compare treatments.;Evaluate the subjective efficacy of the products in the prevention and treatment of diaper rash before (D0) and after 07 (D7) and 21 (D21) days of continuous use of the products. The legal guardians of the participants will respond to a subjective questionnaire with questions about the perception of the use and effect of the investigational product or comparator, with the application of a 5-point agreement scale, with options ranging from “Strongly Agree” to “Strongly Disagree”. | — |
Countries
Brazil
Contacts
Public ContactFlávia Addor
Medcin Instituto da Pele Ltda
Outcome results
None listed