Androgenetic AlopeciaPhase 2NCT00471510
Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
A Phase 2 study testing tetrapeptide aldehyde proteasome inhibitor (NEOSH101) in people with Androgenetic Alopecia, run by Neosil, Inc. at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- May 2007to Feb 2008
- Phase
- Phase 2
- 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men, aged 18 to 49 years, in general good health
- Norwood/Hamilton grades III - IV androgenetic alopecia, with thinning hair in the vertex area
Who cannot join
- Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1
Trial locations and contacts
1 site in 1 country.
Germany1 site
bioskin Institute for Dermatological Research and Development GmbH
Hamburg, 20095
About this study
Official title: A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men
The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.
- Conditions
- Androgenetic Alopecia
- Being tested
- tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
- Keywords
- androgenetic alopecia, male pattern hair loss, male pattern baldness, androgenetic alopecia or male pattern hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetrapeptide aldehyde proteasome inhibitor (NEOSH101)Drug
Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NEOSH101 2% Receives: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) |
| 2 | Experimental | NEOSH101 1% Receives: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) |
| 3 | Experimental | NEOSH101 0.5% Receives: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) |
| 4 | Placebo comparator | Not described Receives: Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density, hair growth rate, hair diameter as measured using the Trichoscan method
Measured: 16 weeks application treatment period followed by 12 weeks observation period
Secondary outcomes (2)
Assessment score of dermal tolerability
Measured: 16 weeks application treatment period followed by 12 weeks observation period
Physician's global assessment score
Measured: 16 weeks application treatment period followed by 12 weeks observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neosil, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johannes Gassmueller, MD, Principal investigator, bioskin Institute for Dermatological Research and Development GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471510
- Sponsor's protocol ID
- NEOSH101-CLIN-AGA004
- Status last verified
- May 2008
- First submitted
- 8 May 2007
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men
- ClinicalTrials.gov ID
- NCT00471510
- Acronym / sponsor ID
- NEOSH101-CLIN-AGA004
- Conditions
- Androgenetic Alopecia
- Keywords
- androgenetic alopecia, male pattern hair loss, male pattern baldness, androgenetic alopecia or male pattern hair loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Neosil, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- First posted
- 10 May 2007 (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.
The purpose of this study is to evaluate the safety and efficacy of three doses of topical NEOSH101 applied once-daily (qd) for 16 weeks in men with thinning hair in the top and center of the scalp (Norwood/Hamilton grades III-IV androgenetic alopecia). Four equally sized treatment groups (35 men each) will receive either NEOSH101 0.5%, NEOSH101 1.0%, NEOSH101 2.0% or placebo. A 12-week observation period will follow the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)NEOSH101 2% |
| 2 | Experimental | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)NEOSH101 1% |
| 3 | Experimental | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101)NEOSH101 0.5% |
| 4 | Placebo comparator | Drug: tetrapeptide aldehyde proteasome inhibitor (NEOSH101) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men, aged 18 to 49 years, in general good health
- Norwood/Hamilton grades III - IV androgenetic alopecia, with thinning hair in the vertex area
Key exclusion criteria (2 listed)
- Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
- Treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1
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 |
|---|---|---|
| tetrapeptide aldehyde proteasome inhibitor (NEOSH101)Study preparation (experimental, placebo comparator) will be applied to the scalp once daily for 16 weeks | Drug | 1, 2, 3, 4 |
Primary outcome
Hair density, hair growth rate, hair diameter as measured using the Trichoscan method
Time frame: 16 weeks application treatment period followed by 12 weeks observation period
2 secondary outcomes
Assessment score of dermal tolerability
Time frame: 16 weeks application treatment period followed by 12 weeks observation period
Physician's global assessment score
Time frame: 16 weeks application treatment period followed by 12 weeks observation period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
Related trials for Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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.
Johannes Gassmueller, MD principal investigator
bioskin Institute for Dermatological Research and Development GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tetrapeptide aldehyde proteasome inhibitor (NEOSH101) in people with Androgenetic Alopecia, run by Neosil, Inc. at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 20 May 2008. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Hair density, hair growth rate, hair diameter as measured using the Trichoscan method (time frame: 16 weeks application treatment period followed by 12 weeks observation period). 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 20 May 2008.