Effect of Pumpkin Seed Oil on Hair Growth in Men With And... | NCT01852487

Studies
Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia

NCT01852487

Sponsor

Dream Plus

Status

Completed

Last Update Posted

May 13, 2013Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Androgenic Alopecia

Interventions

400mg /day during 6 months

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

May 9, 2013

First Submission Date that Met QC Criteria

May 10, 2013

First Posted Date

May 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2013

Last Update Posted Date

May 13, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
400mg /day during 6 months	Dietary Supplement		Pumpkin Seed Oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
investigator assessment score using photographs of scalp hair		at weeks 12 and 24

Secondary Outcomes

Measure	Description	Time Frame
patient self-assessment scores		at weeks 12 and 24

Other Outcomes

Measure	Description	Time Frame
hair analysis using phototrichogram		at weeks 12 and 24

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Yangsan Hospital		Yangsan	Gyeongsangnam-do	626-770	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia
D018761	Multiple Endocrine Neoplasia Type 1

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided