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

August 7, 2012 updated by: Rattapon Thuangtong, Siriraj Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chelate zinc suppliment
15mg Chelate zinc suppliment : additional to standard 5% minoxidil
15 mg Chelate zinc additional to standard 5% minoxidil
Other Names:
  • zinc, Zn
Placebo Comparator: Placebo drug
Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil
Placebo drug instead of Zinc supplement
Other Names:
  • starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare clinical improvement before and after treatment
Time Frame: 6 month
Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist
6 month
Compare hair density before and after treatmen
Time Frame: 6 month
Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.
6 month
Compare average hair shaft diameter before and after treatment
Time Frame: 6 month
Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pateint with Side effect
Time Frame: 6 month
Using side effect record form to record side effect from treatment Count number of pateint with side effect.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 5, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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