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

Primary Purpose

Sensitivity, Contact

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hyaluronic Acid Gel
Sponsored by
Herbarium Laboratorio Botanico Ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sensitivity, Contact

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kosmoscience Ciência e Tecnologia Cosmética Ltda

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

subjects, 18-70 y, healthy

Outcomes

Primary Outcome Measures

Erythema degree or absence
Erythema evaluation according to International Contact Dermatitis Research Group

Secondary Outcome Measures

Full Information

First Posted
March 27, 2020
Last Updated
November 9, 2021
Sponsor
Herbarium Laboratorio Botanico Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT04332445
Brief Title
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.
Official Title
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 3, 2020 (Actual)
Study Completion Date
December 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Herbarium Laboratorio Botanico Ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity, Contact

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Clinical trial, single-arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
subjects, 18-70 y, healthy
Intervention Type
Other
Intervention Name(s)
Hyaluronic Acid Gel
Intervention Description
Health care product - to be apllied on the subject's skin
Primary Outcome Measure Information:
Title
Erythema degree or absence
Description
Erythema evaluation according to International Contact Dermatitis Research Group
Time Frame
39 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Kosmoscience Ciência e Tecnologia Cosmética Ltda
City
Campinas
State/Province
SP
ZIP/Postal Code
13041-315
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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