NCT01852487

Brief Summary

Androgenic alopecia is the most common cause of hair loss in men. Finasteride and minoxidil are available in treatment of androgenetic alopecia, although the former causes decreased libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the scalp. Recently, Pulpkin Seed Oil shows some improved clinical efficacy on scalp hair growth in men with androgenetic alopecia, but there is no evidence to support this. The investigators conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Pumpkin seed oil (400mg/day)therapy in male patients with androgenetic alopecia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
Last Updated

May 13, 2013

Status Verified

May 1, 2013

Enrollment Period

10 months

First QC Date

May 9, 2013

Last Update Submit

May 10, 2013

Conditions

Keywords

Pumpkin seed oilHair growthMen

Outcome Measures

Primary Outcomes (1)

  • investigator assessment score using photographs of scalp hair

    at weeks 12 and 24

Secondary Outcomes (1)

  • patient self-assessment scores

    at weeks 12 and 24

Other Outcomes (1)

  • hair analysis using phototrichogram

    at weeks 12 and 24

Study Arms (2)

Pumpkin Seed Oil

ACTIVE COMPARATOR

400mg/ day during 6 months

Dietary Supplement: 400mg /day during 6 months

sweet potato starch

PLACEBO COMPARATOR

400mg/day during 6months

Interventions

400mg /day during 6 monthsDIETARY_SUPPLEMENT
Pumpkin Seed Oil

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • Androgenetic alopecia of Norwood-Hamilton scale grade II-V

You may not qualify if:

  • Severe medical problems including renal problems, prostate diseases, diabetes mellitus o
  • Patients who took any medicine which can affect the hair growth in recent 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

MeSH Terms

Conditions

AlopeciaMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 13, 2013

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 13, 2013

Record last verified: 2013-05

Locations