Superficial Cryotherapy Versus Microneedling in Alopecia Areata

Study Overview
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Brief Summary
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This study is randomized comparative analytical prospective study that included patients with mild and moderate alopecia areata. Patients was divided into two groups Patients in the first group underwent Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C (Cryotherapy group). Patients in the second group underwent Microneedling (Microneedling group). A total of six sessions were done at 2 weeks interval. Patients were followed-up for next 3 months to evaluate the persistence of hair regrowth after therapy. Patients were assessed at baseline and during follow up using photography, Dermoscopy, SALT score and regrowth scale.

Official Title
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Comparative Study Between the Effect of Superficial Cryotherapy Using Dimethyl Ether and Propane Mixture and Microneedling in Treatment of Alopecia Areata

Conditions
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Alopecia Areata

Intervention / Treatment
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* Procedure: DMEP kit
* Device: Dermapen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ِAlopecia areata patients Exclusion Criteria: Alopecia totalis and universalis ِAge less than four years. ِPregnancy or breast-feeding. ِActive infection at the site alopecia patch(s). ِInflammation ate site of the alopecia patches ِIntolerance to cold. ِAssociated systemic illness such as thyroid, pernicious anaemia, diabetes mellitus, autoimmune connective tissue diseases. ِPrevious treatment for alopecia areata over the last three months.

Ages Eligible for Study
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Minimum Age: 4 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: Patients will be divided into two groups (randomly assigned and comparably cross matched for age and sex) Cryotherapy group (No.= 50): Superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C Microneedling group (No. = 50): Microneedling
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryotherapy group<br>Patients underwent superficial cryotherapy using dimethyl ether and propane (DMEP) at -57C very 2 weeks for maximum six sessions | Procedure: DMEP kit<br>* Superficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C<br>|
| Active Comparator: Microneedling group<br>Patients underwent microneedling 2 weeks for maximum six sessions | Device: Dermapen<br>* Under aseptic precautions, the dermapen was moved on the alopecic patches diagonally, vertically and horizontally 4 to 5 times in each direction Pin point bleeding was taken as an end point<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regrowth Scale | 0 score (regrowth < 10%) no response score (regrowth 11-25%) poor response score (regrowth 26-50%) fair response score (regrowth 51-75%) satisfactory response score (regrowth ≥ 75%) excellent response. | Change in regrowth scale from baseline to 3 months follow after end of sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SALT score | SALT score is the sum of the percentage of hair loss in all the abovementioned areas. For example, if the percentage hair loss in vertex, right profile, left profile, and posterior aspect is 20, 30, 40, and 50% respectively; then, SALT score = (20 × 0.4) = (30 × 0.18) + (40 × 0.18) + (50 × 0.24) = 8 + 5.4 + 7.2 + 12 = 32.6. | Change in salt score from baseline to 3 months follow after end of sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alopecia areata, Microneedling, Cryotherapy