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

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Bimatoprost 0.03% solution
CO2 fractional laser
Sponsored by
Ahmed Hassan Nouh MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia areata, Bimatoprost, CO2 Fractional Laser

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AL-Azhar University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bimatoprost + CO2

CO2

Arm Description

Each patient received three CO2 fractional laser sessions 3 weeks apart with immediate and subsequent daily Bimatoprost 0.03%,1 drop for each 1cm².

Each patient received only three CO2 fractional laser sessions 3 weeks apart

Outcomes

Primary Outcome Measures

Hair regrowth
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

Side effects
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.
Follow up assessment
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.

Full Information

First Posted
October 22, 2022
Last Updated
October 26, 2022
Sponsor
Ahmed Hassan Nouh MD
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1. Study Identification

Unique Protocol Identification Number
NCT05600673
Brief Title
Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata
Official Title
Efficacy of Combined CO2 Fractional Laser With Bimatoprost 0.03% in Treatment of Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Hassan Nouh MD

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia areata, Bimatoprost, CO2 Fractional Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimatoprost + CO2
Arm Type
Experimental
Arm Description
Each patient received three CO2 fractional laser sessions 3 weeks apart with immediate and subsequent daily Bimatoprost 0.03%,1 drop for each 1cm².
Arm Title
CO2
Arm Type
Active Comparator
Arm Description
Each patient received only three CO2 fractional laser sessions 3 weeks apart
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 0.03% solution
Other Intervention Name(s)
Topical treatment of skin lesions
Intervention Description
Topical Bimatoprost 0.03% solution
Intervention Type
Device
Intervention Name(s)
CO2 fractional laser
Other Intervention Name(s)
laser treratment
Intervention Description
CO2 fractional laser treatment
Primary Outcome Measure Information:
Title
Hair regrowth
Description
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
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Side effects
Description
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.
Time Frame
9 weeks
Title
Follow up assessment
Description
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.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
AL-Azhar University Hospital
City
Cairo
ZIP/Postal Code
11865
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31321800
Citation
Al-Dhalimi MA, Al-Janabi MH, Abd Al Hussein RA. The Use of a 1,540 nm Fractional Erbium-Glass Laser in Treatment of Alopecia Areata. Lasers Surg Med. 2019 Dec;51(10):859-865. doi: 10.1002/lsm.23133. Epub 2019 Jul 18.
Results Reference
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PubMed Identifier
25601618
Citation
Choi YM, Diehl J, Levins PC. Promising alternative clinical uses of prostaglandin F2alpha analogs: beyond the eyelashes. J Am Acad Dermatol. 2015 Apr;72(4):712-6. doi: 10.1016/j.jaad.2014.10.012. Epub 2015 Jan 16.
Results Reference
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PubMed Identifier
19620039
Citation
Faghihi G, Andalib F, Asilian A. The efficacy of latanoprost in the treatment of alopecia areata of eyelashes and eyebrows. Eur J Dermatol. 2009 Nov-Dec;19(6):586-7. doi: 10.1684/ejd.2009.0766. Epub 2009 Jul 21.
Results Reference
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PubMed Identifier
32478930
Citation
El-Husseiny R, Elframawy S, Abdallah M. Comparative study between fractional carbon dioxide laser vs intralesional steroid injection in treatment of alopecia areata. Dermatol Ther. 2020 Jul;33(4):e13742. doi: 10.1111/dth.13742. Epub 2020 Jul 9.
Results Reference
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PubMed Identifier
21199096
Citation
Kim WS, Lee HI, Lee JW, Lim YY, Lee SJ, Kim BJ, Kim MN, Song KY, Park WS. Fractional photothermolysis laser treatment of male pattern hair loss. Dermatol Surg. 2011 Jan;37(1):41-51. doi: 10.1111/j.1524-4725.2010.01833.x. Epub 2010 Dec 28.
Results Reference
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PubMed Identifier
21899919
Citation
Smith S, Fagien S, Whitcup SM, Ledon F, Somogyi C, Weng E, Beddingfield FC 3rd. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012 May;66(5):801-6. doi: 10.1016/j.jaad.2011.06.005. Epub 2011 Sep 6.
Results Reference
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PubMed Identifier
20115946
Citation
Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part II. Treatment. J Am Acad Dermatol. 2010 Feb;62(2):191-202, quiz 203-4. doi: 10.1016/j.jaad.2009.10.031.
Results Reference
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PubMed Identifier
21712909
Citation
Vila TO, Camacho Martinez FM. Bimatoprost in the treatment of eyelash universalis alopecia areata. Int J Trichology. 2010 Jul;2(2):86-8. doi: 10.4103/0974-7753.77511.
Results Reference
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PubMed Identifier
31245963
Citation
Wang W, Gegentana, Tonglaga, Bagenna, Li Y. Treatment of alopecia areata with nonablative fractional laser combined with topical minoxidil. J Cosmet Dermatol. 2019 Aug;18(4):1009-1013. doi: 10.1111/jocd.12883. Epub 2019 Jun 6.
Results Reference
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PubMed Identifier
25765294
Citation
Zaher H, Gawdat HI, Hegazy RA, Hassan M. Bimatoprost versus Mometasone Furoate in the Treatment of Scalp Alopecia Areata: A Pilot Study. Dermatology. 2015;230(4):308-13. doi: 10.1159/000371416. Epub 2015 Mar 4.
Results Reference
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Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata

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