Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization of a Scar Gel

NCT06723340 | Completed

• 1 other identifier: ORC-137110_EN24-0262-01_02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.

Conditions

Sensitivity, Contact; Photosensitivity; Phototoxicity

Outcome Measures

Primary Outcomes (1)

• Absence

  Absence of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization under normal conditions and when exposed to sunlight.

  9 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Scar gel

Device: Scar gel

Interventions

Scar gel DEVICE

Scar gel (medical device - topical application)

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of both sexes aged 18 to 70 years;
• Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
• Intact skin in the application area;
• Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
• Understanding, consent, and signing of the Informed Consent Form (ICF).

You may not qualify if:

• Pregnancy or risk of pregnancy/lactation;
• Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
• Immunosuppression due to drugs or active diseases;
• Uncompensated endocrinopathies;
• Personal history of atopy;
• Intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period;
• Plans to bathe in the sea, pool, or sauna during the study;
• Practice of water sports during the study;
• Dermographism;
• Use of oral or topical treatments with vitamin A acid and/or its derivatives up to one month before the start of the study;
• Aesthetic and/or dermatological treatments on the body within three weeks prior to selection;
• Scheduled vaccination during the study period or within three weeks prior to selection;
• History of sensitization, irritation, or photosensitization to topical products;
• Active skin conditions (local and/or widespread) that could interfere with study results;
• Skin reactivity;

Sponsors & Collaborators

• Herbarium Laboratorio Botanico Ltda: lead

Study Sites (1)

Medcin Instituto da Pele Ltda

Osasco, São Paulo, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Phototoxic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Dermatitis, Irritant

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 13, 2025
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

BR (1)