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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Rattapon Thuangtong, Siriraj Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662089
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rattapon Thuangtong, Siriraj Hospital
  Purpose
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.

Condition Intervention Phase
Female Pattern Alopecia Drug: 15 mg Chelate zinc supplement Drug: Placebo drug supplement Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rattapon Thuangtong, Siriraj Hospital:

Primary Outcome Measures:
  • 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

  • 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.

  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chelate zinc suppliment
15mg Chelate zinc suppliment : additional to standard 5% minoxidil
Drug: 15 mg Chelate zinc supplement
15 mg Chelate zinc additional to standard 5% minoxidil
Other Name: zinc, Zn
Placebo Comparator: Placebo drug
Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil
Drug: Placebo drug supplement
Placebo drug instead of Zinc supplement
Other Name: starch

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662089


Contacts
Contact: Rattapon Thuangtong, MD +662 419-7000 ext 4333 rattapongthuangtong@yahoo.com

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Rattapon Thuangtong, MD    +662 419-7000 ext 4333    rattapongthuangtong@yahoo.com   
Sponsors and Collaborators
Siriraj Hospital
  More Information

Responsible Party: Rattapon Thuangtong, Associate Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01662089     History of Changes
Other Study ID Numbers: SirirajH-004
First Submitted: August 5, 2012
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Rattapon Thuangtong, Siriraj Hospital:
Female pattern hair loss

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Zinc
Minoxidil
Chelating Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action