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Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata (AA)

Primary Purpose

Alopecia Areata

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Corticosteroids Acting Locally
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1.Alopecia Areatamultilocuolaris.2.Age from18-50years old. 3.Wash out period is two months. 4.Ophiasis pattern alopecia areata.

Exclusion Criteria:

  • Age less than 12 yearsand more than 40years old. 2.Patient under treatment.3.Patients having another dermatological condition affecting thescalpas eczema.4.Patients with psychiatric disorders.5.Pregnant and lactating females.

Sites / Locations

  • Alazhar faculty of meidicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intralesional cortisosteroid injection

jessener solution

Arm Description

Intralesional corticosteroid injection

topical jessener solution

Outcomes

Primary Outcome Measures

Effecacy of topical jessener solution in treatment of alopecia areata
Effecacy of topical jessener solution in treatment of alopecia areata

Secondary Outcome Measures

Full Information

First Posted
July 13, 2021
Last Updated
July 13, 2021
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04964349
Brief Title
Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata
Acronym
AA
Official Title
Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
October 21, 2021 (Anticipated)
Study Completion Date
November 20, 2021 (Anticipated)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alopecia areata is believed to be an autoimmune disease. Treatment primarily relies on intralesional and topical corticosteroids. This study was conducted to evaluate Jessener Solutionas a potential therapeutic modality of Alopecia Areataversusintralesional steroid as regards the efficacy, safety, tolerability, and patients' satisfaction.
Detailed Description
Background 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.Treatment primarily relies on intralesional and topical corticosteroids.Up till now, there is nouniversally proven therapy that induces and maintains remission of Alopecia Areata in all patients. Aims The Aim of Study is to evaluate the efficacyof Jessener solution versus intralesional steroid in treatment of Alopecia Areata. Patients and Methods The study will include 40 patients diagnosed clinically and dermoscopically as Alopecia Areata with more than two patches of alopecia areata were included. Two treatment modalities with intralesional corticosteroid and topical Jessener Solutionas were performed in two randomly selected patches. Three sessions were done, 3 weeks apart and were followed-up for three months. Evaluation was done using Mac Donald Hull and Norris grading system , Serial photographs and dermoscopic , trichoscopic examination every month will be done and patient will be score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
there are 2 patches of alopecia areata in the same patient one treated with intralesional injection of corticosteroid and the other one will be treated by jessenersolution
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intralesional cortisosteroid injection
Arm Type
Experimental
Arm Description
Intralesional corticosteroid injection
Arm Title
jessener solution
Arm Type
Experimental
Arm Description
topical jessener solution
Intervention Type
Drug
Intervention Name(s)
Corticosteroids Acting Locally
Other Intervention Name(s)
topical jessener solution
Intervention Description
topical application of jessener solution
Primary Outcome Measure Information:
Title
Effecacy of topical jessener solution in treatment of alopecia areata
Description
Effecacy of topical jessener solution in treatment of alopecia areata
Time Frame
6 monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1.Alopecia Areatamultilocuolaris.2.Age from18-50years old. 3.Wash out period is two months. 4.Ophiasis pattern alopecia areata. Exclusion Criteria: Age less than 12 yearsand more than 40years old. 2.Patient under treatment.3.Patients having another dermatological condition affecting thescalpas eczema.4.Patients with psychiatric disorders.5.Pregnant and lactating females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed pr Elshahid, MD
Phone
00201006262271
Ext
dermatology
Email
ahmedandro@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elshahid, MD
Organizational Affiliation
Alazhar faculty of medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Alazhar faculty of meidicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed Elshahid, MD
Phone
+201006262271
Email
ahmedandro@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Jessener Solution Versus Intralesional Steroid in Treatment of Alopecia Areata

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