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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04228029
Recruitment Status : Active, not recruiting
First Posted : January 14, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rana F Hilal, MD, Kasr El Aini Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 20, 2019
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Severity of Alopecia Tool (SALT) score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6months-1 year ]
    evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both

  4. patient satisfaction rate [ Time Frame: 6months-1 year ]
    evaluate efficacy of carboxytherapy versus intralesional steroids versus combination of both



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04228029


Locations
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Egypt
Kasr ElAiny Hospital, Cairo university
Cairo, El Manial, Egypt, 11956
Sponsors and Collaborators
Kasr El Aini Hospital
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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: January 14, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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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:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical