NCT05594316

Brief Summary

Abstract: Alopecia areata is believed to be an autoimmune disease resulting from a breach in the immune privilege of the hair follicles causing non scarring hair loss. Methods: our study included 40 patients from may 2019 to july 2022 diagnosed clinically, dermatoscopically and pathologically as alopecia areata Data were enrolled from department of dermatology and venereology, Al-Hussein hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

May 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

October 19, 2022

Last Update Submit

October 21, 2022

Conditions

Keywords

alopecia areata AA

Outcome Measures

Primary Outcomes (7)

  • Mac Donald Hull and Norris grading system

    regrowth of vellus hair, regrowth of sparse pigmented terminal hair, regrowth of terminal hair with patches of alopecia and regrowth of terminal hair on scalp.

    4 weeks after the end of treatment

  • Scoring of texture of regrown hair

    Fine vellus hair, Intermediate hair,Normal coarse hair

    after each session and 4 weeks after the end of treatment

  • Scoring of pigmentation of regrown hair

    Partially pigmented, Moderately pigmented, Normally pigmented

    after each session and 4 weeks after the end of treatment

  • Scoring for density of hair regrowth

    No hair growth, 1%-25% growth, 26%-50% growth, 51%-75% growth and 76%-100% growth

    after each session and 4 weeks after the end of treatment

  • Scoring of overall response at the end of the study

    No response, Minimal response, Moderate response, Good response and Excellent response

    after each session and 4 weeks after the end of treatment

  • histopathological changes

    appearance of lymphocytes around hair follicle, appearance of new blood vessels and size of thickness of hair follicles

    after each session and 4 weeks after the end of treatment

  • trichoscopic parameters

    determine exclamation mark hairs, black dots, yellow dots and broken hairs

    after each session and 4 weeks after the end of treatment

Study Arms (1)

single group

OTHER

Trichloroacetic acid

Drug: Trichloroacetic acid

Interventions

5\. Patients will be subjected to 3 session of trichloroacetic acid 35% one month apart.

single group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata.

You may not qualify if:

  • Age less than 16 and more than 60years old. Alopecia areata of the face.
  • Patient under treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Azhar university, faculty of medicine

Cairo, Egypt

Location

Al-Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Trichloroacetic Acid

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer of dermatology,venerology and andrology

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 26, 2022

Study Start

May 1, 2019

Primary Completion

August 1, 2022

Study Completion

October 19, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations