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The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement

Primary Purpose

Female Pattern Alopecia

Status

Unknown status

Phase

Phase 1

Locations

Thailand

Study Type

Interventional

Intervention

15 mg Chelate zinc supplement

Placebo drug supplement

About this trial

This is an interventional treatment trial for Female Pattern Alopecia focused on measuring Female pattern hair loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 )

Exclusion Criteria:

Underlying disease ; Anemia, Diabetes, chronic alcoholism, previous gastrointestinal surgery, short bowel syndrome, Crohn's disease, digestive disorder, hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency
Psychologic disorder trichotillomania
Diet control
Pregnancy or lactation
On supplement diet within 3 month prior to trial

Sites / Locations

Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chelate zinc suppliment

Placebo drug

Arm Description

15mg Chelate zinc suppliment : additional to standard 5% minoxidil

Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil

Outcomes

Primary Outcome Measures

Compare clinical improvement before and after treatment

Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist

Compare hair density before and after treatmen

Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.

Compare average hair shaft diameter before and after treatment

Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.

Secondary Outcome Measures

Number of pateint with Side effect

Using side effect record form to record side effect from treatment Count number of pateint with side effect.

Full Information

NCT ID

NCT01662089

First Posted

August 5, 2012

Last Updated

August 7, 2012

Sponsor

Siriraj Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01662089

Brief Title

The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement

Official Title

A Pilot Study of the Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Oral Chelated Zinc Supplement

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Siriraj Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient. But the type of patient, efficacy, and side effect in detail of zinc supplement are not well characterized. The purpose of this study is to determine efficacy and side effect of chelated zinc in FPHL who using 5%minoxidil solution.

Detailed Description

5%minoxidil solution is standard treatment for Female pattern hair loss (FPHL) patient. We gave 15mg chelate Zinc / Placebo drug to patient as an additional trace element. Then measure growth of hair by Global photograph, Microscope hair count, micrometer and record case and side effect during 10 months of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Female Pattern Alopecia

Keywords

Female pattern hair loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chelate zinc suppliment

Arm Type

Experimental

Arm Description

15mg Chelate zinc suppliment : additional to standard 5% minoxidil

Arm Title

Placebo drug

Arm Type

Placebo Comparator

Arm Description

Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil

Intervention Type

Drug

Intervention Name(s)

15 mg Chelate zinc supplement

Other Intervention Name(s)

zinc, Zn

Intervention Description

15 mg Chelate zinc additional to standard 5% minoxidil

Intervention Type

Drug

Intervention Name(s)

Placebo drug supplement

Other Intervention Name(s)

starch

Intervention Description

Placebo drug instead of Zinc supplement

Primary Outcome Measure Information:

Title

Compare clinical improvement before and after treatment

Description

Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist

Time Frame

6 month

Title

Compare hair density before and after treatmen

Description

Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.

Time Frame

6 month

Title

Compare average hair shaft diameter before and after treatment

Description

Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Number of pateint with Side effect

Description

Using side effect record form to record side effect from treatment Count number of pateint with side effect.

Time Frame

6 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 ) Exclusion Criteria: Underlying disease ; Anemia, Diabetes, chronic alcoholism, previous gastrointestinal surgery, short bowel syndrome, Crohn's disease, digestive disorder, hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency Psychologic disorder trichotillomania Diet control Pregnancy or lactation On supplement diet within 3 month prior to trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rattapon Thuangtong, MD

Phone

+662 419-7000

Ext

4333

rattapongthuangtong@yahoo.com

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rattapon Thuangtong, MD

Phone

+662 419-7000

Ext

4333

rattapongthuangtong@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement

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