Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata

October 26, 2022 updated by: Ahmed Hassan Nouh MD

Efficacy of Combined CO2 Fractional Laser With Bimatoprost 0.03% in Treatment of Alopecia Areata

The goal of this study is to evaluate the efficacy and safety of combined CO2 fractional laser with Bimatoprost 0.03% as novel treatment of alopecia areata.

The main question to study is will the bimatoprost facilitate hair growth if added to fractional CO2 laser treatment in Alopecia areata.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study included 30 patients who were diagnosed clinically and dermoscopically as alopecia areata with age ranged between 16-55 years. The patients are divided into 2 groups: Group I, received fractional laser sessions with immediate and daily Bimatoprost application and Group II, received only frequent Laser sessions. Laser sessions were given to each patch once every 3 weeks, the procedure was repeated for 3 times.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • 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 Locations

  • Egypt
      • Cairo, Egypt, 11865
        • Al-Azhar University hospital

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 53 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with alopecia areata of the scalp (multilocuolaris or single patch).
  • Patient aged from 16- 55 years old in both sex.
  • Other treatment wash out period is two months.

Exclusion Criteria:

  • Ophiasis pattern and other patterns of alopecia areata.
  • Chronic diseases of liver, heart, kidney and blood
  • Pregnant women
  • Infections of skin in site of intervention

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimatoprost + CO2
Each patient received three CO2 fractional laser sessions 3 weeks apart with immediate and subsequent daily Bimatoprost 0.03%,1 drop for each 1cm².
Drug: Bimatoprost 0.03% solution
Topical Bimatoprost 0.03% solution
Other Names:
  • Topical treatment of skin lesions
Device: CO2 fractional laser
CO2 fractional laser treatment
Other Names:
  • laser treratment
Active Comparator: CO2
Each patient received only three CO2 fractional laser sessions 3 weeks apart
Device: CO2 fractional laser
CO2 fractional laser treatment
Other Names:
  • laser treratment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair regrowth
Time Frame: 9 weeks

Efficacy of treatment assessed using a prognostic scoring system proposed by Mcdonald Hull and Norris for density, pigmentation, and texture of growing hair.

Grade 1 - Regrowth of vellus hair Grade 2 - Regrowth of sparse pigmented terminal hair Grade 3 - Regrowth of terminal hair with patches of alopecia Grade 4 - Regrowth of terminal hair on scalp
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 9 weeks

The patients were asked about any side effects noticed every session by questionnaire.

The patient satisfaction scale: - the patients were asked at final visit to rate the overall satisfaction according to whether the patient was not satisfied, slightly satisfied, satisfied or very satisfied.

The patients were asked to report any complications as; erythema, pain, ulceration, burning sensation, ecchymosis, infection, post-inflammatory hyperpigmentation or any allergic manifestations.
9 weeks
Follow up assessment
Time Frame: 9 weeks
The patients were followed up 3 weeks after the end of treatment sessions to detect any recurrence, complications or worsening of the lesions & final results of treatment.
9 weeks

Collaborators and Investigators

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

Sponsor

Ahmed Hassan Nouh MD

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)

January 1, 2019

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

October 22, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlAzharUE

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

product manufactured in and exported from the U.S.

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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