Androgenic AlopeciaNCT01852487
Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia
A study testing 400mg /day during 6 months in people with Androgenic Alopecia, run by Dream Plus at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- 400mg /day during 6 months
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Androgenetic alopecia of Norwood-Hamilton scale grade II-V
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 626-770
About this study
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.
- Conditions
- Androgenic Alopecia
- Being tested
- 400mg /day during 6 months
- Keywords
- Pumpkin seed oil, Hair growth, Men
- Medical subject headings
- Alopecia, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400mg /day during 6 monthsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Pumpkin Seed Oil | Active comparator | 400mg/ day during 6 months Receives: Dietary Supplement: 400mg /day during 6 months |
| sweet potato starch | Placebo comparator | 400mg/day during 6months |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigator assessment score using photographs of scalp hair
Measured: at weeks 12 and 24
Secondary outcomes (1)
patient self-assessment scores
Measured: at weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dream Plus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Young Hye Cho, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852487
- Sponsor's protocol ID
- Pumpkin0912
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 13 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT01852487
- Acronym / sponsor ID
- Pumpkin0912
- Conditions
- Androgenic Alopecia
- Keywords
- Pumpkin seed oil, Hair growth, Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dream PlusIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pumpkin Seed Oil | Active comparator | Dietary Supplement: 400mg /day during 6 months400mg/ day during 6 months |
| sweet potato starch | Placebo comparator | –400mg/day during 6months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 65 years of age
- Androgenetic alopecia of Norwood-Hamilton scale grade II-V
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 400mg /day during 6 months | Dietary supplement | Pumpkin Seed Oil |
Primary outcome
investigator assessment score using photographs of scalp hair
Time frame: at weeks 12 and 24
1 secondary outcome
patient self-assessment scores
Time frame: at weeks 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
Related trials for Androgenic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
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Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
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Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400mg /day during 6 months in people with Androgenic Alopecia, run by Dream Plus at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigator assessment score using photographs of scalp hair (time frame: at weeks 12 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.