Assessment of skin irritability after using a health product

Not Applicable

• Conditions: Skin; Accidental Injuries; Wounds, Nonpenetrating; Wounds, Penetrating; skin disease

• Registration Number: RBR-4wkdqx4
• Lead Sponsor: Medicin Instituto da Pele Ltda

Brief Summary

The objective of the study is to prove the absence of irritation (primary and accumulated dermal irritation) and allergy (dermal sensitization) reactions to the investigational product in the studied population through the compatibility test. Single-center, blind, non-comparative clinical study to evaluate primary and accumulated dermal irritability and dermal sensitization, with the aim of proving the topical compatibility of the investigational product. The study was carried out under maximized conditions, in which patches containing the product were applied to the participants' backs to prove the absence of the potential for irritation and allergy. The practical part of the study lasted six weeks, with three weeks of application of the product, two weeks of rest for participants and a new application of the product in a virgin area, in the sixth week (challenge). The readings were carried out according to the reading scale recommended by the International Contact Dermatitis Research Group (ICDRG). Dermatological evaluations were carried out at the beginning and end of the study, or when there was evidence of a positive or adverse reaction. After the Primary Dermal Irritability study period, none of the 55 participants who completed this stage showed a skin reaction; After the Accumulated Irritability period, none of the 53 participants who completed this stage showed a skin reaction; After the Dermal Sensitization study period, none of the 53 participants who completed this stage presented a skin reaction. No potential for Primary Dermal Irritation was observed. No potential for Accumulated Dermal Irritation was observed. No potential for dermal sensitization was observed. The product can be declared Dermatologically tested.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-29
• Study Completion: 2022-11-03
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Participants of both sexes aged 18 to 70 years; Phototype: I, II, III and IV (according to adapted scale); Skin of the application region integrates; Agreeing to follow the test procedures and to attend the clinic on the days and times determined for medical evaluations and for application and reading of dressings; Understanding, consent and signing of the Free and Informed Consent Term (ICF)

Exclusion Criteria

Participants who have been diagnosed with COVID 19 in the last 4 weeks or who have symptoms of fever, dry cough, tiredness, body aches or other discomforts; Pregnancy or risk of pregnancy and/or lactation (when women); Use of anti-inflammatory drugs and/or immunosuppressive drugs for up to three months before selection; Immunosuppression by drugs or active disease; Decompensated endocrinopathies; Personal history of atopy; Intense sun exposure or tanning sessions up to 15 days before the assessment or during the study period; Expect intense exposure to sunlight or tanning sessions during the study period; Provision of bathing in the sea, 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 3 weeks before selection; History of sensitization, irritation or photosensitization 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; Known or suspected history of intolerance to any ingredient in study products (test or comparative product); History of non-adherence 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 participating in the study. If yes, it should be described under observation in the clinical record

Study & Design

• Study Type: Intervention
• Study Design: Not specified