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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600673
• Other study ID #: AlAzharUE
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: October 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Bimatoprost 0.03% solution
Topical Bimatoprost 0.03% solution

Device:
• CO2 fractional laser
CO2 fractional laser treatment

Locations

Country	Name	City	State
Egypt	AL-Azhar University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Hassan Nouh MD

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. Review. — View Citation

Choi YM, Diehl J, Levins PC. Promising alternative clinical uses of prostaglandin F2a 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. Review. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	9 weeks
Secondary	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.	9 weeks