Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids

Study Overview
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Brief Summary
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Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion. Treatment period is 3 months followed by a follow-up period of 2 months.

Official Title
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Does Carboxytherapy Play a Role in Alopecia Areata Either Solely or in Combination? Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids

Conditions
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Alopecia Areata

Intervention / Treatment
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* Device: Carboxytherapy
* Drug: Intralesional Steroid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: early localized scalp alopecia areata patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent. Exclusion Criteria: pregnant, and lactating females and those with unrealistic expectation. Alopecia totalis or universalis or ophiasis or cicatrising alopecia Usage of systemic treatment of alopecia areata 2 months prior to the study. Any scalp lesion within the treated area Bleeding diathesis, severe anemia or platelet disorders Medical conditions such as autoimmune diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carboxytherapy<br> | Device: Carboxytherapy<br>* Carbon dioxide (CO2) gas in injection form<br>|
| Active Comparator: Intralesional steroids<br> | Drug: Intralesional Steroid Injection<br>* triamcinolone acetonide 8 mg/mL<br>|
| Active Comparator: Combination of carboxytherapy and intralesional steroids<br> | Device: Carboxytherapy<br>* Carbon dioxide (CO2) gas in injection form<br>Drug: Intralesional Steroid Injection<br>* triamcinolone acetonide 8 mg/mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Alopecia Tool (SALT) score | evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both Minimum value is 0% and maximum value is100% the higher the score the more the hair loss | 6months-1 year | 
| Dermoscopy | evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both through counting number dystrophic hair, tapered hair, regrowing hair, black dots, and yellow dots | 6months-1 year | 
| blinded observer evaluation by use of photography | evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both | 6months-1 year | 
| patient satisfaction rate | evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both | 6months-1 year |