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Dermatological Assessment of Photoallergy and Phototoxicity

Primary Purpose

Sensitivity, Contact

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Health care product (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:

  • Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19;
  • Agreement to perform a molecular test for the detection of COVID-19 to enter the study;
  • 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;
  • Age from 18 to 70 years;
  • Phototype (Fitzpatrick): II and III;
  • Any gender

Exclusion Criteria:

  • Participants who belong to the risk group for COVID-19, that is, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems as belonging to the risk group;
  • Skin marks in the experimental area;
  • Active dermatoses (local or widespread);
  • Pregnant or breastfeeding women;
  • History of allergic reactions, irritation or intense feelings of discomfort to topical products;
  • History of phototoxic or photoallergic reactions;
  • History of allergy to materials used in the study;
  • History of atopy;
  • Personal or family pathological history of skin cancer;
  • History of pathologies aggravated or triggered by ultraviolet radiation;
  • Carriers of immunodeficiencies;
  • Intense sun exposure or tanning session up to 15 days before the initial evaluation;
  • Predicted intense sun exposure or tanning session during the course of the study;
  • Predicted bathing in the sea, pool or bathtub during the study;
  • Participants who practice 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;
  • Use of topical or systemic photosensitizing drugs;
  • 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 or having participated in another clinical trial terminated less than 7 days before selection, in case the previous trial is acceptable in use;
  • Being or having participated in another clinical trial terminated less than 21 days ago, in case the previous trial is compatible or Adverse Reaction investigative;
  • History of absence of adherence or unwillingness to adhere to the study protocol;
  • Professionals directly involved in the execution of this protocol and their relatives.
  • Participants who have COVID-19, or who present symptoms indicative of the disease in the last 14 days.
  • Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study.

Sites / Locations

  • Allergisa Pesquisa Dermato-Cosmética Ltda

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

subjects, 18-70 y, healthy

Arm Description

subjects, 18-70 y, healthy

Outcomes

Primary Outcome Measures

Absence
Absence occurence of phototoxicity and photoallergy

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
June 12, 2021
Sponsor
Herbarium Laboratorio Botanico Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT04250623
Brief Title
Dermatological Assessment of Photoallergy and Phototoxicity
Official Title
Dermatological Assessment of Photoallergy and Phototoxicity Under Controlled and Maximised Conditions.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
May 21, 2021 (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 will be conducted with 40 subjects*, aged 18 to 70 years. The product will be applied on the right and/or left participant back for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 24 hours. Medical evaluation will be available throughout the study to assess possible adverse events. The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of photoallergy and phototoxicity. * 29 completed the trial
Detailed Description
40 subjects, aged 18 to 70 years, phototypes II to III (according to Fitzpatrick classification). The patch test will be used to verify the absence of photoallergy and phototoxicity by the investigational products. The products will be applied twice a week for 3 consecutive weeks, as they are over semi-occlusive dressings. The product will remain in contact with the skin for 24 hours, after product removal the area will be irradiated with ultraviolet lamp A and B (UVA/UVB). Then, the procedure will be repeated after 10 days of wash out.

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
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subjects, 18-70 y, healthy
Arm Type
Experimental
Arm Description
subjects, 18-70 y, healthy
Intervention Type
Other
Intervention Name(s)
Health care product (gel)
Intervention Description
hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)
Primary Outcome Measure Information:
Title
Absence
Description
Absence occurence of phototoxicity and photoallergy
Time Frame
6 weeks

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: Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19; Agreement to perform a molecular test for the detection of COVID-19 to enter the study; 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; Age from 18 to 70 years; Phototype (Fitzpatrick): II and III; Any gender Exclusion Criteria: Participants who belong to the risk group for COVID-19, that is, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems as belonging to the risk group; Skin marks in the experimental area; Active dermatoses (local or widespread); Pregnant or breastfeeding women; History of allergic reactions, irritation or intense feelings of discomfort to topical products; History of phototoxic or photoallergic reactions; History of allergy to materials used in the study; History of atopy; Personal or family pathological history of skin cancer; History of pathologies aggravated or triggered by ultraviolet radiation; Carriers of immunodeficiencies; Intense sun exposure or tanning session up to 15 days before the initial evaluation; Predicted intense sun exposure or tanning session during the course of the study; Predicted bathing in the sea, pool or bathtub during the study; Participants who practice 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; Use of topical or systemic photosensitizing drugs; 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 or having participated in another clinical trial terminated less than 7 days before selection, in case the previous trial is acceptable in use; Being or having participated in another clinical trial terminated less than 21 days ago, in case the previous trial is compatible or Adverse Reaction investigative; History of absence of adherence or unwillingness to adhere to the study protocol; Professionals directly involved in the execution of this protocol and their relatives. Participants who have COVID-19, or who present symptoms indicative of the disease in the last 14 days. Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study.
Facility Information:
Facility Name
Allergisa Pesquisa Dermato-Cosmética Ltda
City
Campinas
State/Province
SP
ZIP/Postal Code
13084-791
Country
Brazil

12. IPD Sharing Statement

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Dermatological Assessment of Photoallergy and Phototoxicity

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