Alpha-Bisabolol Gel With Antihistamine Action

Sponsor

Universidade do Vale do Sapucai (Other)

Overall Status

Completed

CT.gov ID

NCT05022108

Collaborator

(none)

Enrollment

Location

Arm

8.6

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wounds and Injuries	Biological: Alpha bisabolol gel	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Alpha-Bisabolol Gel With Antihistamine Action

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antihistamine test 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.	Biological: Alpha bisabolol gel Using alpha bisabolol gel with a concentration of 0.5%, 2,5% or 5% to treat sensitized area with histamine.

Arm

Intervention/Treatment

Experimental: Antihistamine test

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.

Biological: Alpha bisabolol gel

Using alpha bisabolol gel with a concentration of 0.5%, 2,5% or 5% to treat sensitized area with histamine.

Outcome Measures

Primary Outcome Measures

Measure of the area (cm2) sensitized with histamine only [15 minutes]
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 [15 minutes]
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 [15 minutes]
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 [15 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.