NCT04228029

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 8, 2020

Last Update Submit

January 10, 2020

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • blinded observer evaluation by use of photography

    evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both

    6months-1 year

  • patient satisfaction rate

    evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both

    6months-1 year

Study Arms (3)

Carboxytherapy

ACTIVE COMPARATOR
Device: Carboxytherapy

Intralesional steroids

ACTIVE COMPARATOR
Drug: Intralesional Steroid Injection

Combination of carboxytherapy and intralesional steroids

ACTIVE COMPARATOR
Device: CarboxytherapyDrug: Intralesional Steroid Injection

Interventions

CarboxytherapyDEVICE

Carbon dioxide (CO2) gas in injection form

CarboxytherapyCombination of carboxytherapy and intralesional steroids
Intralesional Steroid InjectionDRUG

triamcinolone acetonide 8 mg/mL

Combination of carboxytherapy and intralesional steroidsIntralesional steroids

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr ElAiny Hospital, Cairo university

Cairo, El Manial, 11956, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33742252DERIVED

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of dermatology, faculty of Medicine, Cairo University.

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 14, 2020

Study Start

August 20, 2019

Primary Completion

February 20, 2020

Study Completion

April 20, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

EG(1)