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Alpha-Bisabolol Gel With Antihistamine Action

NCT ID: NCT05022108

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-12-20

Brief Summary

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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

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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.

Conditions

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Wounds and Injuries

Keywords

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Histamine Antagonists Phytotherapy Wounds and injuries Bites and Stings Plant Oils

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Alpha bisabolol gel

Intervention Type BIOLOGICAL

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

Interventions

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Alpha bisabolol gel

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role lead

Responsible Party

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Adriana Rodrigues dos Anjos Mendonça

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana R dos Anjos Mendonça, PhD

Role: PRINCIPAL_INVESTIGATOR

Vale do Sapucaí University

Locations

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Vale do Sapucaí University

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Antihistamine

Identifier Type: -

Identifier Source: org_study_id