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

NCT ID: NCT04228029

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2020-04-20

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.

Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Carboxytherapy

Group Type ACTIVE_COMPARATOR

Carboxytherapy

Intervention Type DEVICE

Carbon dioxide (CO2) gas in injection form

Intralesional steroids

Group Type ACTIVE_COMPARATOR

Intralesional Steroid Injection

Intervention Type DRUG

triamcinolone acetonide 8 mg/mL

Combination of carboxytherapy and intralesional steroids

Group Type ACTIVE_COMPARATOR

Carboxytherapy

Intervention Type DEVICE

Carbon dioxide (CO2) gas in injection form

Intralesional Steroid Injection

Intervention Type DRUG

triamcinolone acetonide 8 mg/mL

Interventions

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Carboxytherapy

Carbon dioxide (CO2) gas in injection form

Intervention Type DEVICE

Intralesional Steroid Injection

triamcinolone acetonide 8 mg/mL

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rana F Hilal, MD

Lecturer of dermatology, faculty of Medicine, Cairo University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr ElAiny Hospital, Cairo university

Cairo, El Manial, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 33742252 (View on PubMed)

Other Identifiers

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KasrEliniH

Identifier Type: -

Identifier Source: org_study_id

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