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Modified SALT Score for Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Triamcinolone Acetonide
saline
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alopecia Areata

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kasr El Ainy university hospital, Faulty of medicine,Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intralesional Steroids

Control

Arm Description

Outcomes

Primary Outcome Measures

Percentage involvement
Degree of severity expressed as a percentage
Modified Severity of Alopecia Tool (mSALT) score
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

Secondary Outcome Measures

Full Information

First Posted
May 29, 2020
Last Updated
May 29, 2020
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04412148
Brief Title
Modified SALT Score for Alopecia Areata
Official Title
Modified SALT Score for Assessment of Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
August 1, 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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

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
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intralesional Steroids
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
intralesional injection of saline
Primary Outcome Measure Information:
Title
Percentage involvement
Description
Degree of severity expressed as a percentage
Time Frame
6months to 1 year
Title
Modified Severity of Alopecia Tool (mSALT) score
Description
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
Time Frame
6 months to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Hilal, MD
Phone
1001488869
Ext
+20
Email
rana.hilal@kasralainy.edu.eg
Facility Information:
Facility Name
Kasr El Ainy university hospital, Faulty of medicine,Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rana Hilal, MD
Phone
1001488869
Ext
+20
Email
rana.hilal@kasralainy.edu.eg

12. IPD Sharing Statement

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Modified SALT Score for Alopecia Areata

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