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

NCT05600673 | Completed Phase 1 DMC

• 1 other identifier: AlAzharUE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Alopecia areata; Bimatoprost; CO2 Fractional Laser

Outcome Measures

Primary Outcomes (1)

• 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

  9 weeks

Secondary Outcomes (2)

• Side effects

  9 weeks

• Follow up assessment

  9 weeks

Study Arms (2)

Bimatoprost + CO2

EXPERIMENTAL

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; Device: CO2 fractional laser

CO2

ACTIVE COMPARATOR

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

Device: CO2 fractional laser

Interventions

Bimatoprost 0.03% solution DRUG

Topical Bimatoprost 0.03% solution

Also known as: Topical treatment of skin lesions

Bimatoprost + CO2

CO2 fractional laser DEVICE

CO2 fractional laser treatment

Also known as: laser treratment

Bimatoprost + CO2; CO2

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmed Hassan Nouh MD: lead

Study Sites (1)

AL-Azhar University Hospital

Cairo, 11865, Egypt

Location

Related Publications (10)

• 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.

  PMID: 31321800 RESULT

• 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.

  PMID: 25601618 RESULT

• 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.

  PMID: 19620039 RESULT

• 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.

  PMID: 32478930 RESULT

• 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.

  PMID: 21199096 RESULT

• 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.

  PMID: 21899919 RESULT

• 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.

  PMID: 20115946 RESULT

• 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.

  PMID: 21712909 RESULT

• 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.

  PMID: 31245963 RESULT

• 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.

  PMID: 25765294 RESULT

MeSH Terms

Conditions

Alopecia Areata

Interventions

Bimatoprost; Solutions

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dermatology, Venereology and Andrology department

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 31, 2022
• Study Start: January 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: May 1, 2021
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)