Alpha-Bisabolol Gel With Antihistamine Action

Wounds and Injuries Clinical Trial

Official title:

Alpha-Bisabolol Gel With Antihistamine Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022108
• Other study ID #: Antihistamine
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: August 2021
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 20, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Brazil	Vale do Sapucaí University	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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