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

Phase 4

• Conditions: Alopecia Areata
• Interventions: Device: Carboxytherapy; Drug: Intralesional Steroid Injection

• Registration Number: NCT04228029
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-20
• Status Verified: 2020-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Study First Posted: 2020-01-14
• Last Update Posted: 2020-01-14
• Primary Completion: 2020-02-20
• Study Completion: 2020-04-20

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Combination of carboxytherapy and intralesional steroids	Intralesional Steroid Injection	-
Intralesional steroids	Intralesional Steroid Injection	-
Carboxytherapy	Carboxytherapy	-
Combination of carboxytherapy and intralesional steroids	Carboxytherapy	-

Primary Outcome Measures

Name	Time	Method
Severity of Alopecia Tool (SALT) score	6months-1 year	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
Dermoscopy	6months-1 year	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
blinded observer evaluation by use of photography	6months-1 year	evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
patient satisfaction rate	6months-1 year	evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both

Trial Locations

Locations (1)

Kasr ElAiny Hospital, Cairo university; 🇪🇬 Cairo, El Manial, Egypt