NCT05022108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

June 12, 2021

Last Update Submit

August 25, 2021

Conditions

Wounds and Injuries

Keywords

Histamine AntagonistsPhytotherapyWounds and injuriesBites and StingsPlant Oils

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Antihistamine test

EXPERIMENTAL

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

Interventions

Alpha bisabolol gelBIOLOGICAL

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

Antihistamine test

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vale do Sapucaí University

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Conditions

Wounds and InjuriesBites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced Disorders

Study Officials

  • Adriana R dos Anjos Mendonça, PhD

    Vale do Sapucaí University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2021

First Posted

August 26, 2021

Study Start

April 1, 2020

Primary Completion

August 1, 2020

Study Completion

December 20, 2020

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)