Modified SALT Score for Alopecia Areata | NCT04412148

Studies
Modified SALT Score for Alopecia Areata

NCT04412148

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2020Actual

Enrollment

20Estimated

Phase

Phase 4

Conditions

Alopecia Areata

Interventions

Triamcinolone Acetonide
saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jul 1, 2020Estimated

Completion Date

Aug 1, 2020Estimated

First Submitted Date

May 29, 2020

First Submission Date that Met QC Criteria

May 29, 2020

First Posted Date

Jun 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2020

Last Update Posted Date

Jun 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intralesional Steroids	Active Comparator		Drug: Triamcinolone Acetonide
Control	Placebo Comparator		Other: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triamcinolone Acetonide	Drug	intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions	Intralesional Steroids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage involvement	Degree of severity expressed as a percentage	6months to 1 year
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	6 months to 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rana Hilal, MD	Contact	1001488869	+20	rana.hilal@kasralainy.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr El Ainy university hospital, Faulty of medicine,Cairo university	Recruiting	Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000506	Alopecia Areata

Ancestor Terms

ID	Term
D000505	Alopecia
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014222	Triamcinolone Acetonide
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D014221	Triamcinolone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided