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

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04228029
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Device: Carboxytherapy; Drug: Intralesional Steroid Injection	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 20, 2019
• Anticipated Primary Completion Date: Feb 20, 2020
• Anticipated Study Completion Date: Apr 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Carboxytherapy	Device: Carboxytherapy; Carbon dioxide (CO2) gas in injection form
Active Comparator: Intralesional steroids	Drug: Intralesional Steroid Injection; triamcinolone acetonide 8 mg/mL
Active Comparator: Combination of carboxytherapy and intralesional steroids	Device: Carboxytherapy; Carbon dioxide (CO2) gas in injection form; Drug: Intralesional Steroid Injection; triamcinolone acetonide 8 mg/mL

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. blinded observer evaluation by use of photography [6months-1 year]

   evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both

4. patient satisfaction rate [6months-1 year]

   evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr ElAiny Hospital, Cairo university	Cairo	El Manial	Egypt	11956

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rana F Hilal, MD, Lecturer of dermatology, faculty of Medicine, Cairo University., Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT04228029
• Other Study ID Numbers: KasrEliniH
• First Posted: Jan 14, 2020
• Last Update Posted: Jan 14, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Alopecia; Alopecia Areata

Study Results

No Results Posted as of Jan 14, 2020