Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.

NCT04332445 | Completed

• 1 other identifier: HB032-19
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study for health care product safety assessment. The research is going to conducted with 55 subjects, aged 18 to 70 years. The product is applied on the right and/or left participant back. After a wash out, the product is reapplied. Medical evaluation will be available throughout the study to assess possible adverse events. The main of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy, photoallergy and phototoxicity.

Conditions

Sensitivity, Contact

Outcome Measures

Primary Outcomes (1)

• Erythema degree or absence

  Erythema evaluation according to International Contact Dermatitis Research Group

  39 days

Study Arms (1)

Experimental

EXPERIMENTAL

subjects, 18-70 y, healthy

Other: Hyaluronic Acid Gel

Interventions

Hyaluronic Acid Gel OTHER

Health care product - to be apllied on the subject's skin

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:

• Healthy participants;
• Non-injured skin in the test region;
• Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
• Ability to consent to participation in the study;
• Phototype (Fitzpatrick): II and III;

You may not qualify if:

• Pregnant or breastfeeding women;
• Use of the following systemic drugs: antihistamines, non-hormonal anti-inflammatory drugs and corticoids;
• History of allergy to cosmetics, topical products or research product;
• Localized or widespread dermatological diseases or inflammatory dermatoses active and nerve damage in the test region;
• Personal or family pathological history of skin cancer;
• Use of topical or systemic photosensitizing medication;
• History of phototoxic, photoallergic reactions, dermatoses caused by light, atopy, pathologies aggravated or triggered by ultraviolet radiation;
• Photo-induced pathologies;
• Frequent exposure to the sun or tanning chambers;
• Participated in an allergenicity study in a period of less than 4 weeks from the start of the study;
• Skin marks in the experimental area that interfere with the evaluation of possible reactions;
• Active dermatoses;
• Forecast to take a bath in the sea, pool or sauna during the study;
• Participants who play water sports;
• Dermography;

Sponsors & Collaborators

• Herbarium Laboratorio Botanico Ltda: lead

Study Sites (1)

Kosmoscience Ciência e Tecnologia Cosmética Ltda

Campinas, São Paulo, 13041-315, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Clinical trial, single-arm

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: October 26, 2020
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: November 10, 2021

Record last verified: 2021-11

Locations

BR (1)