- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01662089
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Rattapon Thuangtong, MD
- Phone Number: 4333 +662 419-7000
- Email: rattapongthuangtong@yahoo.com
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Siriraj Hospital
-
Contact:
- Rattapon Thuangtong, MD
- Phone Number: 4333 +662 419-7000
- Email: rattapongthuangtong@yahoo.com
-
-
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:
|
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:
|
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SirirajH-004
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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