Alpha-Bisabolol Gel With Antihistamine Action

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Biological: Alpha bisabolol gel

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Pouso Alegre, Minas Gerais, Brazil, 37550-000
      • Vale do Sapucaí University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15 minutes
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	15 minutes
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	15 minutes
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	15 minutes

Collaborators and Investigators

• Sponsor: Universidade do Vale do Sapucai

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: June 12, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Wounds and injuries; Histamine Antagonists; Phytotherapy; Bites and Stings; Plant Oils
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Antihistamine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No