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New Treatment of Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Trichloroacetic acid
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring alopecia areata AA

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Al-Azhar university, faculty of medicine
  • Al-Azhar university

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single group

Arm Description

Trichloroacetic acid

Outcomes

Primary Outcome Measures

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.
Scoring of texture of regrown hair
Fine vellus hair, Intermediate hair,Normal coarse hair
Scoring of pigmentation of regrown hair
Partially pigmented, Moderately pigmented, Normally pigmented
Scoring for density of hair regrowth
No hair growth, 1%-25% growth, 26%-50% growth, 51%-75% growth and 76%-100% growth
Scoring of overall response at the end of the study
No response, Minimal response, Moderate response, Good response and Excellent response
histopathological changes
appearance of lymphocytes around hair follicle, appearance of new blood vessels and size of thickness of hair follicles
trichoscopic parameters
determine exclamation mark hairs, black dots, yellow dots and broken hairs

Secondary Outcome Measures

Full Information

First Posted
October 19, 2022
Last Updated
October 21, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05594316
Brief Title
New Treatment of Alopecia Areata
Official Title
Efficacy of Trichloroacetic Acid in Patients of Alopecia Areata : Clinico-histopathological Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
For each patient the following will be done : History taking including ( age, sex, disease duration, family history, history of drug intake, smoking and history of any associated disease ). All patients will give a written, informed consent for induction. Basic photographs will be taken to assess site, size (by cm), number, Extent of the patch using D5300 camera with lens (18-55). Patients will be subjected to 3 session of trichloroacetic acid (TCA) 35% one month apart. serial photographs and dermoscopic examination every month will be done and patient will be score. Efficacy will be assessed using prognostic scoring system for density, pigmentation, and texture of growing hair. histopathological examination will be done before the first session and one month after third session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
alopecia areata AA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single group
Arm Type
Other
Arm Description
Trichloroacetic acid
Intervention Type
Drug
Intervention Name(s)
Trichloroacetic acid
Intervention Description
5. Patients will be subjected to 3 session of trichloroacetic acid 35% one month apart.
Primary Outcome Measure Information:
Title
Mac Donald Hull and Norris grading system
Description
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.
Time Frame
4 weeks after the end of treatment
Title
Scoring of texture of regrown hair
Description
Fine vellus hair, Intermediate hair,Normal coarse hair
Time Frame
after each session and 4 weeks after the end of treatment
Title
Scoring of pigmentation of regrown hair
Description
Partially pigmented, Moderately pigmented, Normally pigmented
Time Frame
after each session and 4 weeks after the end of treatment
Title
Scoring for density of hair regrowth
Description
No hair growth, 1%-25% growth, 26%-50% growth, 51%-75% growth and 76%-100% growth
Time Frame
after each session and 4 weeks after the end of treatment
Title
Scoring of overall response at the end of the study
Description
No response, Minimal response, Moderate response, Good response and Excellent response
Time Frame
after each session and 4 weeks after the end of treatment
Title
histopathological changes
Description
appearance of lymphocytes around hair follicle, appearance of new blood vessels and size of thickness of hair follicles
Time Frame
after each session and 4 weeks after the end of treatment
Title
trichoscopic parameters
Description
determine exclamation mark hairs, black dots, yellow dots and broken hairs
Time Frame
after each session and 4 weeks after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata. Exclusion Criteria: Age less than 16 and more than 60years old. Alopecia areata of the face. Patient under treatment.
Facility Information:
Facility Name
Al-Azhar university, faculty of medicine
City
Cairo
Country
Egypt
Facility Name
Al-Azhar university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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New Treatment of Alopecia Areata

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