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

Sponsor
Ahmed Hassan Nouh MD (Other)
Overall Status
Completed
CT.gov ID
NCT05600673
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
28
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bimatoprost 0.03% solution
  • Device: CO2 fractional laser
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
In this design, subjects are randomized to 2 study arms and each study arm will be allocated a different intervention. After randomization each participant will stay in their assigned treatment arm for the duration of the study.In this design, subjects are randomized to 2 study arms and each study arm will be allocated a different intervention. After randomization each participant will stay in their assigned treatment arm for the duration of the study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Combined CO2 Fractional Laser With Bimatoprost 0.03% in Treatment of Alopecia Areata
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 30, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hair regrowth [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

    Secondary Outcome Measures

    1. Side effects [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.

    2. Follow up assessment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AL-Azhar University Hospital Cairo Egypt 11865

    Sponsors and Collaborators

    • Ahmed Hassan Nouh MD

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Hassan Nouh MD, Lecturer of Dermatology, Venereology and Andrology department, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT05600673
    Other Study ID Numbers:
    • AlAzharUE
    First Posted:
    Oct 31, 2022
    Last Update Posted:
    Oct 31, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Ahmed Hassan Nouh MD, Lecturer of Dermatology, Venereology and Andrology department, Al-Azhar University
    Alopecia areata
    Bimatoprost
    CO2 Fractional Laser
    Additional relevant MeSH terms:
    Alopecia
    Alopecia Areata
    Bimatoprost

    Study Results

    No Results Posted as of Oct 31, 2022