New Treatment of Alopecia Areata

Efficacy of Trichloroacetic Acid in Patients of Alopecia Areata : Clinico-histopathological Study

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Trichloroacetic acid

Detailed Description

For each patient the following will be done :

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al-Azhar University
  • Cairo, Egypt
    • Al-Azhar University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single group; Trichloroacetic acid	Drug: Trichloroacetic acid; 5. Patients will be subjected to 3 session of trichloroacetic acid 35% one month apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: alopecia areata AA
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: hossam pulse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No