Fractional Laser Versus Radiofrequency in Androgenetic Alopecia

Study Overview
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Brief Summary
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Patients with Androgenetic alopecia will be randomized into 2 groups; Group FCO2 receiving Fractional CO2 or Group FRF receiving Fractional Microneedling Radiofrequency.

Detailed Description
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Group FCO2 will be to receiving fractional CO2 to one randomized side of the scalp, and Group FRF will be receiving Fractional Microneedling radiofrequency to one randomized side of the scalp. All patients will receive 4 sessions with 4-week intervals.each session will be followed by immediate topical application of 6 puffs (=1 mL) of minoxidil 5% solution twice daily and also in between the sessions and during follow up period

Official Title
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Fractional Microneedling Radiofrequency Versus Fractional Carbon Dioxide Laser in Combination With Minoxidil for the Treatment of Androgenetic Alopecia

Conditions
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Androgenic Alopecia

Intervention / Treatment
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* Procedure: FCO2
* Procedure: FRF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • both genders are included. Patients above 18 years old. Exclusion Criteria: • Patients with patchy hair loss. Patients with Telogen Effluvium or diffuse alopecia areata. Patients with cicatricial alopecias. Patients with associated inflammatory scalp disorders such as psoriasis or seborrheic dermatitis. Patients with collagen vascular disorders. Prior use of topical steroids on scalp in the previous 2 weeks. Prior use of systemic steroids in the previous 1 month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FCO2<br>Fractional Carbon dioxide laser | Procedure: FCO2<br>* Fractional Carbon dioxide laser<br>|
| Active Comparator: FRF<br>Fractional Microneedling Radiofrequency | Procedure: FRF<br>* Fractional Microneedling Radiofrequency<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global improvement Assessment | Photographs will be taken with a Canon camera under controlled light in approximately the same position, taken at baseline, after 4 treatment sessions (16 weeks post treatment) and 2 months after follow-up (24 weeks post treatment). First clinical assessment will be performed based on the clinical change from baseline at 16 weeks post treatment. Change in the clinical will be measured on a 6 point scale; (-1) worsening, (0) no improvement, (1) less than 25% improvement, (2) 25-50% improvement, (3) 50-75% improvement, (4) more than 75% improvement. A higher numerical means a better outcome. | 6months-1 year | 
| Clinical Global improvement Assessment | Photographs will be taken with a Canon camera under controlled light in approximately the same position, taken at baseline, after 4 treatment sessions (16 weeks post treatment) and 2 months after follow-up (24 weeks post treatment). Second clinical assessment will be performed based on the clinical change from 16 weeks post treatment to 24 weeks post treatment. Change in the clinical will be measured on a 6 point scale; (-1) worsening, (0) no improvement, (1) less than 25% improvement, (2) 25-50% improvement, (3) 50-75% improvement, (4) more than 75% improvement. A higher numerical means a better outcome. | 6months-1 year | 
| Phototrichogram assessment. | A phototrichogram system (Dino-Lite; AnMo Electronics, Taiwan)will be used to evaluate the number of hairs. A higher numerical means a better outcome. | months-1 year | 
| Phototrichogram assessment. | A phototrichogram system (Dino-Lite; AnMo Electronics, Taiwan)will be used to evaluate the thickness of hairs. A higher numerical means a better outcome. | 2 months | 
| Patient satisfaction | Participants will be also asked to give their assessment on a scale of 4, (0) no satisfaction (1) slight satisfation, (2) moderate satisfaction, (3) marked satisfaction. A higher numerical means a better outcome. | 6months-1 year |