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Alpha-Bisabolol Gel With Antihistamine Action

Primary Purpose

Wounds and Injuries

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Alpha bisabolol gel
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Histamine Antagonists, Phytotherapy, Wounds and injuries, Bites and Stings, Plant Oils

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • participants without allergy-related diseases, non-pregnant women and who agreed to cooperate in carrying out the research by signing the consent form aged between 18 and 60 years of both sexes.

Exclusion Criteria:

  • participants who had a history of previous anaphylaxis, extensive dermatitis, use of antihistamines, colds or steroids.
  • participants who had a negative reaction to histamine and/or withdrew their consent at any stage of the study.

Sites / Locations

  • Vale do Sapucaí University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antihistamine test

Arm Description

The forearm was sensitized at four points (A, B, C and D). Point A: positive control sensitized with a drop of histamine at a concentration of 10 mg / Ml. Point B: histamine was applied and immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol were applied. Point D was sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test reading at each point occurred 15 minutes after the procedure.

Outcomes

Primary Outcome Measures

Measure of the area (cm2) sensitized with histamine only
Positive control sensitized with a drop of histamine at a concentration of 10 mg / Ml, and after 15 minutes the area sensitized will be measure
Measure of the area (cm2) sensitized by histamine treated with 0,5% Alpha bisabolol
Histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 0.5%, and after 15 minutes the area sensitized will be measure
Measure of the area sensitized by histamine treated with 2,5% Alpha bisabolol
Histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 2,5% will applied, and after 15 minutes the area sensitized will be measure
Measure of the area (cm2) sensitized by histamine treated with 5% Alpha bisabolol
It will be sensitized with a drop of histamine and immediately with 5.0% alpha-bisabolol gel, and after 15 minutes the area sensitized will be measure

Secondary Outcome Measures

Full Information

First Posted
June 12, 2021
Last Updated
August 25, 2021
Sponsor
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT05022108
Brief Title
Alpha-Bisabolol Gel With Antihistamine Action
Official Title
Alpha-Bisabolol Gel With Antihistamine Action
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

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

5. Study Description

Brief Summary
It will be developed and evaluated the antihistamine potential of a gel containing alpha-bisabolol. Method: Interventional and cross-sectional study, with convenience sampling, conducted with 20 volunteers. The forearm will be sensitized at four points (A, B, C and D). Point A: positive control will be sensitized with a drop of histamine at a concentration of 10 mg / Ml. Point B: histamine will apply and immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol will apply. Point D will be sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test reading at each point will occur 15 minutes after the procedure. For the analysis of the results, the T Test will be applied.
Detailed Description
Context:. Phytotherapy has been widely used to treat health with a prophylactic, curative and palliative purpose due to its easy access and low cost when compared to other available drug forms. Some plant species have antiallergic and anti-inflammatory properties that can be used to help contain signs and damage in allergic reactions, triggered mainly by histamine such as: pain, redness, heat and edema. Alpha-bisabolol, extracted from Candeia, has several applications in the treatment of illnesses, however, there are no studies on the therapeutic potential for antihistamine. Objective: To develop and evaluate the antihistamine potential of a gel containing alpha-bisabolol. Method: Pilot study, interventional, cross-sectional study, with convenience sampling, conducted with 20 volunteers. The forearm will be sensitized at four points (A, B, C and D). Point A: positive control sensitized with a drop of histamine at a concentration of 10 mg / Ml. Point B: histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol will be applied. Point D will be sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test reading at each point will occur 15 minutes after the procedure. For the analysis of the results, the T Test will be applied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
Histamine Antagonists, Phytotherapy, Wounds and injuries, Bites and Stings, Plant Oils

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antihistamine test
Arm Type
Experimental
Arm Description
The forearm was sensitized at four points (A, B, C and D). Point A: positive control sensitized with a drop of histamine at a concentration of 10 mg / Ml. Point B: histamine was applied and immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol were applied. Point D was sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test reading at each point occurred 15 minutes after the procedure.
Intervention Type
Biological
Intervention Name(s)
Alpha bisabolol gel
Intervention Description
Using alpha bisabolol gel with a concentration of 0.5%, 2,5% or 5% to treat sensitized area with histamine.
Primary Outcome Measure Information:
Title
Measure of the area (cm2) sensitized with histamine only
Description
Positive control sensitized with a drop of histamine at a concentration of 10 mg / Ml, and after 15 minutes the area sensitized will be measure
Time Frame
15 minutes
Title
Measure of the area (cm2) sensitized by histamine treated with 0,5% Alpha bisabolol
Description
Histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 0.5%, and after 15 minutes the area sensitized will be measure
Time Frame
15 minutes
Title
Measure of the area sensitized by histamine treated with 2,5% Alpha bisabolol
Description
Histamine will be applied and immediately after, the alpha bisabolol gel with a concentration of 2,5% will applied, and after 15 minutes the area sensitized will be measure
Time Frame
15 minutes
Title
Measure of the area (cm2) sensitized by histamine treated with 5% Alpha bisabolol
Description
It will be sensitized with a drop of histamine and immediately with 5.0% alpha-bisabolol gel, and after 15 minutes the area sensitized will be measure
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participants without allergy-related diseases, non-pregnant women and who agreed to cooperate in carrying out the research by signing the consent form aged between 18 and 60 years of both sexes. Exclusion Criteria: participants who had a history of previous anaphylaxis, extensive dermatitis, use of antihistamines, colds or steroids. participants who had a negative reaction to histamine and/or withdrew their consent at any stage of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana R dos Anjos Mendonça, PhD
Organizational Affiliation
Vale do Sapucaí University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vale do Sapucaí University
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37550-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Alpha-Bisabolol Gel With Antihistamine Action

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