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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04228029
• Other study ID #: KasrEliniH
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 20, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: January 2020
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Device:
• Carboxytherapy
Carbon dioxide (CO2) gas in injection form

Drug:
• Intralesional Steroid Injection
triamcinolone acetonide 8 mg/mL

Locations

Country	Name	City	State
Egypt	Kasr ElAiny Hospital, Cairo university	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	blinded observer evaluation by use of photography	evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both	6months-1 year
Primary	patient satisfaction rate	evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both	6months-1 year