Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids

January 10, 2020 updated by: Rana F Hilal, MD, Kasr El Aini Hospital

Does Carboxytherapy Play a Role in Alopecia Areata Either Solely or in Combination? Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids

Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion.

Treatment period is 3 months followed by a follow-up period of 2 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
    • El Manial
      • Cairo, El Manial, Egypt, 11956
        • Kasr ElAiny Hospital, Cairo university

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

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • early localized scalp alopecia areata
  • patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent.

Exclusion Criteria:

  • pregnant, and lactating females and those with unrealistic expectation.
  • Alopecia totalis or universalis or ophiasis or cicatrising alopecia
  • Usage of systemic treatment of alopecia areata 2 months prior to the study.
  • Any scalp lesion within the treated area
  • Bleeding diathesis, severe anemia or platelet disorders
  • Medical conditions such as autoimmune diseases.

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: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carboxytherapy
Device: Carboxytherapy
Carbon dioxide (CO2) gas in injection form
Active Comparator: Intralesional steroids
Drug: Intralesional Steroid Injection
triamcinolone acetonide 8 mg/mL
Active Comparator: Combination of carboxytherapy and intralesional steroids
Device: Carboxytherapy
Carbon dioxide (CO2) gas in injection form
Drug: Intralesional Steroid Injection
triamcinolone acetonide 8 mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Alopecia Tool (SALT) score
Time Frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both Minimum value is 0% and maximum value is100% the higher the score the more the hair loss
6months-1 year
Dermoscopy
Time Frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both through counting number dystrophic hair, tapered hair, regrowing hair, black dots, and yellow dots
6months-1 year
blinded observer evaluation by use of photography
Time Frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
6months-1 year
patient satisfaction rate
Time Frame: 6months-1 year
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
6months-1 year

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 20, 2019

Primary Completion (Anticipated)

February 20, 2020

Study Completion (Anticipated)

April 20, 2020

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KasrEliniH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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