Evaluation of the Allergy potential of a Cosmetic Product (HRIPT+Phototest)

Not Applicable

• Conditions: Diaper Rash; M01.774.500

• Registration Number: RBR-5cbvq6p
• Lead Sponsor: Medcin Instituto da Pele Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-12
• Last Update Posted: 18 September 2023
• Study Completion: 2023-12-13

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.