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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 because the information has not been verified recently.
Verified August 2012 by Siriraj Hospital.
Recruitment status was  Recruiting
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

August 5, 2012
August 7, 2012
January 2012
October 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01662089 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Female Pattern Alopecia
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Rattapon Thuangtong, MD +662 419-7000 ext 4333 rattapongthuangtong@yahoo.com
Thailand
 
NCT01662089
SirirajH-004
Yes
Rattapon Thuangtong, Siriraj Hospital
Siriraj Hospital
Not Provided
Not Provided
Siriraj Hospital
August 2012

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