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Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization

Primary Purpose

Sensitivity, Contact

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Health care product
Sponsored by
Herbarium Laboratorio Botanico Ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sensitivity, Contact

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Agreement to comply with safety guidelines to minimize contamination risks to COVID-19;
  • Agreement to perform a molecular test to detect 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 59 years;
  • Phototype (Fitzpatrick): I to IV;
  • All sex.

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 doctor deems to belong to the risk group;
  • Pregnant or breastfeeding women;
  • Skin marks in the experimental area that interfere with the evaluation of possible skin reactions;
  • Active dermatoses;
  • Background of allergic reactions, irritation or intense discomfort sensations to topical use products;
  • History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.);
  • Sensation of discomfort with temperature changes (too hot/very cold) and/or when in the air conditioning;
  • Participants with a history of allergy to materials used in the study;
  • 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;
  • Prediction of intense sun exposure or tanning session during the course of the study;
  • Expected to bathe in the sea, pool or bathtub during the conduct of the study;
  • Participants who practice water sports;
  • Dermography;
  • Aesthetic and/or body dermatological treatment until 03 weeks before the selection;
  • Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids until 2 weeks before selection or, considering deposit corticoids, the interval shall be 1 month before selection;
  • Treatment with acidic vitamin A and/or its derivatives via oral or topical up to 1 month before the start of the study;
  • Vaccination during the study or up to 3 weeks before the study;
  • Being or having participated in another clinical trial terminated less than 7 days before selection, if the previous trial is acceptable in use;
  • Being or having participated in another clinical trial terminated less than 21 days before the selection, in case the previous trial is compatible or Adverse Reaction investigative;
  • Any condition not mentioned above that, in the opinion of the investigator, may compromise the assessment of the trial;
  • History of no adherence or unwillingness to adhere to the study protocol;
  • Professionals directly involved in the conduct of this protocol and their families.

Sites / Locations

  • Allergisa Pesquisa Dermato-Cosmética Ltda

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

subjects, 18-59 y, healthy

Arm Description

patch test with investigation product

Outcomes

Primary Outcome Measures

Absence
Absence of the occurrence of reactions of primary, accumulated dermal irritation and of allergic reactions by sensitization by the investigational products.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
May 6, 2021
Sponsor
Herbarium Laboratorio Botanico Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT04248556
Brief Title
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization
Official Title
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization Under Controlled and Maximised Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
April 17, 2021 (Actual)
Study Completion Date
April 17, 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 92 subjects, aged 18 to 59 years. The product will be applied on the right and/or left back of the research participants for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 48 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 irritability and/or allergy.
Detailed Description
92 subjects, aged 18 to 59 years, phototypes I to IV (according to Fitzpatrick classification). The patch test will be used to verify the absence of primary and cumulative dermal irritation reactions and sensitization allergic reactions by the investigational products. The products will be applied as they are over semi-occlusive dressings.

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

8. Arms, Groups, and Interventions

Arm Title
subjects, 18-59 y, healthy
Arm Type
Experimental
Arm Description
patch test with investigation product
Intervention Type
Other
Intervention Name(s)
Health care product
Intervention Description
Health care product (gel) - to be applied on the participant's skin
Primary Outcome Measure Information:
Title
Absence
Description
Absence of the occurrence of reactions of primary, accumulated dermal irritation and of allergic reactions by sensitization by the investigational products.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Agreement to comply with safety guidelines to minimize contamination risks to COVID-19; Agreement to perform a molecular test to detect 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 59 years; Phototype (Fitzpatrick): I to IV; All sex. 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 doctor deems to belong to the risk group; Pregnant or breastfeeding women; Skin marks in the experimental area that interfere with the evaluation of possible skin reactions; Active dermatoses; Background of allergic reactions, irritation or intense discomfort sensations to topical use products; History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.); Sensation of discomfort with temperature changes (too hot/very cold) and/or when in the air conditioning; Participants with a history of allergy to materials used in the study; 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; Prediction of intense sun exposure or tanning session during the course of the study; Expected to bathe in the sea, pool or bathtub during the conduct of the study; Participants who practice water sports; Dermography; Aesthetic and/or body dermatological treatment until 03 weeks before the selection; Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids until 2 weeks before selection or, considering deposit corticoids, the interval shall be 1 month before selection; Treatment with acidic vitamin A and/or its derivatives via oral or topical up to 1 month before the start of the study; Vaccination during the study or up to 3 weeks before the study; Being or having participated in another clinical trial terminated less than 7 days before selection, if the previous trial is acceptable in use; Being or having participated in another clinical trial terminated less than 21 days before the selection, in case the previous trial is compatible or Adverse Reaction investigative; Any condition not mentioned above that, in the opinion of the investigator, may compromise the assessment of the trial; History of no adherence or unwillingness to adhere to the study protocol; Professionals directly involved in the conduct of this protocol and their families.
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

Learn more about this trial

Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization

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