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

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ClinicalTrials.gov Identifier: NCT01662089
Recruitment Status : Unknown
Verified August 2012 by Rattapon Thuangtong, Siriraj Hospital.
Recruitment status was:  Recruiting
First Posted : August 10, 2012
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):
Rattapon Thuangtong, Siriraj Hospital

Tracking Information
First Submitted Date  ICMJE August 5, 2012
First Posted Date  ICMJE August 10, 2012
Last Update Posted Date August 10, 2012
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement
Official Title  ICMJE A Pilot Study of the Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Oral Chelated Zinc Supplement
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Female Pattern Alopecia
Intervention  ICMJE
  • Drug: 15 mg Chelate zinc supplement
    15 mg Chelate zinc additional to standard 5% minoxidil
    Other Name: zinc, Zn
  • Drug: Placebo drug supplement
    Placebo drug instead of Zinc supplement
    Other Name: starch
Study Arms  ICMJE
  • Experimental: Chelate zinc suppliment
    15mg Chelate zinc suppliment : additional to standard 5% minoxidil
    Intervention: Drug: 15 mg Chelate zinc supplement
  • Placebo Comparator: Placebo drug
    Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil
    Intervention: Drug: Placebo drug supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 7, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01662089
Other Study ID Numbers  ICMJE SirirajH-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rattapon Thuangtong, Siriraj Hospital
Study Sponsor  ICMJE Siriraj Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Siriraj Hospital
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP