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Modified SALT Score for Alopecia Areata

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412148
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Rana F Hilal, MD, Kasr El Aini Hospital

Brief Summary:
Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Triamcinolone Acetonide Other: saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Modified SALT Score for Assessment of Alopecia Areata
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intralesional Steroids Drug: Triamcinolone Acetonide
intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions

Placebo Comparator: Control Other: saline
intralesional injection of saline




Primary Outcome Measures :
  1. Percentage involvement [ Time Frame: 6months to 1 year ]
    Degree of severity expressed as a percentage

  2. Modified Severity of Alopecia Tool (mSALT) score [ Time Frame: 6 months to 1 year ]
    New Score calculating severity (hair density) and area as a number minimum value is 0 and maximum value is 105 the higher the number of the score the worse the affection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent.

Exclusion Criteria:

  • • pregnant, and lactating females

    • Alopecia totalis or universalis or ophiasis or cicatritial 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): NCT04412148


Contacts
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Contact: Rana Hilal, MD 1001488869 ext +20 rana.hilal@kasralainy.edu.eg

Locations
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Egypt
Kasr El Ainy university hospital, Faulty of medicine,Cairo university Recruiting
Cairo, Egypt
Contact: Rana Hilal, MD    1001488869 ext +20    rana.hilal@kasralainy.edu.eg   
Sponsors and Collaborators
Kasr El Aini Hospital
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Responsible Party: Rana F Hilal, MD, Principal Investigator, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04412148    
Other Study ID Numbers: EgymSALT
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action