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

July 13, 2021 updated by: Ahmed Rashad Elshahid, Al-Azhar University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Alazhar faculty of meidicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intralesional cortisosteroid injection
Intralesional corticosteroid injection
Drug: Corticosteroids Acting Locally
topical application of jessener solution
Other Names:
  • topical jessener solution
Experimental: jessener solution
topical jessener solution
Drug: Corticosteroids Acting Locally
topical application of jessener solution
Other Names:
  • topical jessener solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effecacy of topical jessener solution in treatment of alopecia areata
Time Frame: 6 monthes
Effecacy of topical jessener solution in treatment of alopecia areata
6 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Chair: Ahmed Elshahid, MD, Alazhar faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Anticipated)

October 21, 2021

Study Completion (Anticipated)

November 20, 2021

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alazhar faculty of medicine
  • Ahmed Kadah (Other Identifier: Alazhar faculty of medicine)
  • Eman Abd-ellatif (Other Identifier: Alazhar faculty of medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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