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Alpha-Bisabolol Gel With Antihistamine Action

Alpha-Bisabolol Gel With Antihistamine Action

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05022108
Enrollment
20
Registered
2021-08-26
Start date
2020-04-01
Completion date
2020-12-20
Last updated
2021-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds and Injuries

Keywords

Histamine Antagonists, Phytotherapy, Wounds and injuries, Bites and Stings, Plant Oils

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.

Interventions

BIOLOGICALAlpha bisabolol gel

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

Sponsors

Universidade do Vale do Sapucai
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Measure of the area (cm2) sensitized with histamine only15 minutesPositive 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 bisabolol15 minutesHistamine 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 bisabolol15 minutesHistamine 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 bisabolol15 minutesIt 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026