Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
Primary Purpose
Alopecia Areata
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Carboxytherapy
Intralesional Steroid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
Eligibility Criteria
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.
Sites / Locations
- Kasr ElAiny Hospital, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Carboxytherapy
Intralesional steroids
Combination of carboxytherapy and intralesional steroids
Arm Description
Outcomes
Primary Outcome Measures
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
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
blinded observer evaluation by use of photography
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
patient satisfaction rate
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
Secondary Outcome Measures
Full Information
NCT ID
NCT04228029
First Posted
January 8, 2020
Last Updated
January 10, 2020
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04228029
Brief Title
Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Anticipated)
Study Completion Date
April 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carboxytherapy
Arm Type
Active Comparator
Arm Title
Intralesional steroids
Arm Type
Active Comparator
Arm Title
Combination of carboxytherapy and intralesional steroids
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Carboxytherapy
Intervention Description
Carbon dioxide (CO2) gas in injection form
Intervention Type
Drug
Intervention Name(s)
Intralesional Steroid Injection
Intervention Description
triamcinolone acetonide 8 mg/mL
Primary Outcome Measure Information:
Title
Severity of Alopecia Tool (SALT) score
Description
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
Time Frame
6months-1 year
Title
Dermoscopy
Description
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
Time Frame
6months-1 year
Title
blinded observer evaluation by use of photography
Description
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
Time Frame
6months-1 year
Title
patient satisfaction rate
Description
evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both
Time Frame
6months-1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kasr ElAiny Hospital, Cairo university
City
Cairo
State/Province
El Manial
ZIP/Postal Code
11956
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
33742252
Citation
Metwally D, Abdel-Fattah R, Hilal RF. Comparative study for treatment of alopecia areata using carboxy therapy, intralesional corticosteroids, and a combination of both. Arch Dermatol Res. 2022 Mar;314(2):167-182. doi: 10.1007/s00403-021-02201-6. Epub 2021 Mar 19.
Results Reference
derived
Learn more about this trial
Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
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