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

This study is currently recruiting participants.
Verified August 2012 by Siriraj Hospital
Sponsor:
Information provided by (Responsible Party):
Rattapon Thuangtong, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01662089
First received: August 5, 2012
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Minoxidil
U.S. FDA Resources

Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • Compare clinical improvement before and after treatment [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rattapon Thuangtong, Associate Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01662089     History of Changes
Other Study ID Numbers: SirirajH-004
Study First Received: August 5, 2012
Last Updated: August 7, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Siriraj Hospital:
Female pattern hair loss

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Zinc
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013