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

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.

Study Overview

• Status: Completed
• Conditions: Sensitivity, Contact
• Intervention / Treatment: Other: Hyaluronic Acid Gel

Detailed Description

Subjects phototypes I to IV (according to Fitzpatrick classification). The products is applied over semi-occlusive dressings, remaing in contact with the skin.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13041-315
      • Kosmoscience Ciência e Tecnologia Cosmética Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;
• Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks prior to selection or, considering deposit corticoids, the interval shall be 1 month prior to selection;

• Treatment with acid vitamin A and/or its derivatives via oral or topical until

  1 month before the beginning of the study;

• Aesthetic and/or body dermatological treatment until 3 weeks before selection;
• Vaccination during the study or until 3 weeks before the study;
• Being participated in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; subjects, 18-70 y, healthy	Other: Hyaluronic Acid Gel; Health care product - to be apllied on the subject's skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema degree or absence	Erythema evaluation according to International Contact Dermatitis Research Group	39 days

Collaborators and Investigators

• Sponsor: Herbarium Laboratorio Botanico Ltda

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): December 3, 2020
• Study Completion (Actual): December 3, 2020

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Irritant; Photosensitivity Disorders; Dermatitis, Allergic Contact; Dermatitis, Contact; Dermatitis, Phototoxic; Dermatitis, Photoallergic; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: HB032-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No