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

Phase 1

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: Bimatoprost 0.03% solution; Device: CO2 fractional laser

• Registration Number: NCT05600673
• Lead Sponsor: Ahmed Hassan Nouh MD

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-01-30
• Study Completion: 2021-05-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

AL-Azhar University Hospital; 🇪🇬 Cairo, Egypt