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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Bimatoprost 0.03% solution
* Device: CO2 fractional laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost + CO2<br>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<br>* Topical Bimatoprost 0.03% solution<br>* Other names: Topical treatment of skin lesions;Device: CO2 fractional laser<br>* CO2 fractional laser treatment<br>* Other names: laser treratment;|
| Active Comparator: CO2<br>Each patient received only three CO2 fractional laser sessions 3 weeks apart | Device: CO2 fractional laser<br>* CO2 fractional laser treatment<br>* Other names: laser treratment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia areata, Bimatoprost, CO2 Fractional Laser