Androgenetic AlopeciaNCT01309191
Microarray Analysis of Scalp Biopsies After Minoxidil Treatment
A study testing Minoxidil in people with Androgenetic Alopecia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or 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?
- Minoxidil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a male
- Is in general good health
- Has a diagnosis of androgenic alopecia with hair loss in both the vertex and the frontal area, Hamilton (as modified by Norwood) Type IV-V
- Has read, signed and received a copy of the Informed Consent Form prior to initiation of the study procedures
- Is willing to follow all instructions and able to participate in the entire study, returning for all specified visits
- Between the age of 18 to 49 years old, inclusively
Who cannot join
- Evidence of concomitant skin diseases of the scalp including but not limited to dandruff, seborrheic dermatitis, psoriasis, lichenoid eruption, tinea capitis or other scalp infections or infestations.
- Has a history of recurring dandruff symptoms or seborrheic dermatitis, evidence of excoriations, or other history that might indicate an inability to use the products supplied for the duration of the study.
- Has consistently used any medicated shampoos or anti-dandruff shampoo treatment products over the past year or at all during the two months prior to the Baseline visit.
- Has a history of alopecia areata, totalis, universalis or any other hair loss disorder except male pattern baldness.
- Evidence of significant scalp scarring.
- Has skin cancer or actinic keratoses currently within the balding area.
Show all 39Show fewer
- Has a history of skin cancer on the scalp.
- Has undergone a hair transplant or scalp reduction surgery.
- Has exhibited hypersensitivity, rash or other abnormal skin reactions, symptoms or lesions to topically applied hair care products in the past year.
- Has been diagnosed with hypothyroidism or hyperthyroidism within the past year.
- Has taken or applied any of the following medications known to induce hypotrichosis (abnormal hair loss), and/or hypertrichosis (abnormal hair growth).
- Medications taken or used in the past 6 months
- Finasteride -hair growth product (PropeciaÒ or ProscarÒ)
- Topical or systemic hair growth products (commercial or investigative) e.g. minoxidil (RogaineÒ), NioxinÒ, dutasteride
- Chemotherapeutic agents
- Systemic Retinoids (e.g. acitretin, etretinate, isotretinoin, Vitamin A > 5,000 IU (per day)
- Immunosuppressives (e.g. tacrolimus, cyclosporine A)
- Antimetabolic agents. (e.g. FludaraÒ, LeustatinÒ
- Antimitotic agents
- Anti-androgens (e.g. flutamide, spironolactone, cyproterone acetate)
- Androgens (e.g. testosterone, methyl testosterone, danazol)
- DHEA, androstenedione
- Ketaconazole -systemic (antifungal)
- Ginseng (herb)
- Saw Palmetto
- Diazoxide (hyperglycemic, antihypertensive agent)
- Anticoagulants (e.g. dicumarol, heparin, warfarin)
- Interferon
- Beta blockers (e.g. AcebutololÒ,, AtenololÒ, propranolol, TimololÒ, MetoprololÒ)
- Antiepileptic and anticonvulsants (e.g. valproic acid, carbamazepine, diphenylhydantoin)
- Antithyroid drugs (e.g. carbimazole, methimazole, methylthiouracil, propylthiouracil)
- Topical corticosteroids on scalp or applied to more than 25% of the body surface area
- Systemic corticosteroids
- Topical ketaconazole shampoo or cream
- Has a significant medical condition including, but not limited to:
- Hypertension (acceptable if controlled by other than a beta blocker); angina, myocardial infarction; history of fainting or dizziness; history of kidney or urinary disorders; diabetes; hemophilia or any condition determined by the Investigator as significant and therefore considered a cause for exclusion
- Has recently been on, or is currently on a medically managed weight reduction program.
- Has had a significant febrile illness (high fever lasting several days) within 8 weeks of the Baseline visit.
- Has participated in an investigational drug study within 4 weeks of the Baseline visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Study Center, UH Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Microarray Analysis of Scalp Biopsies in Subjects With Androgenetic Alopecia Before and After the Use of Topical Minoxidil
The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
Read the detailed description
The most common type of hair loss is androgenetic alopecia (AGA), also known as male pattern balding, or hereditary thinning. In AGA, there is a gradual transformation of large terminal hair follicles to miniaturized ones under the influence of circulating androgens that produce smaller and finer hairs with a shorter anagen cycle. This transformation, which can be seen as early as the prepubescent years, occurs only in certain regions of the scalp: the frontal hairline, top and vertex scalp. The temporo-occipital region is largely unaffected even in those with extensive balding.
The first drug to be approved for the FDA for the treatment of AGA was topical minoxidil solution (TMS). Despite its successful use, the mechanism of action of TMS is not well understood. Minoxidil is a potent vasodilator and potassium channel opener, but its mechanism of action in promoting hair regrowth appears to be independent of its vasodilation properties. Improved knowledge of the changes in gene expression associated with AGA before and after treatment with TMS and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of TMS. Furthermore, there is potential for identification of those patients who would best respond to or benefit from treatment.
- Conditions
- Androgenetic Alopecia
- Being tested
- Minoxidil, Placebo
- Keywords
- Androgenetic Alopecia, Minoxidil, Microarray
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinoxidilOther
Also called Rogaine
Over the counter Rogaine, twice a day for 8 weeks
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil | Experimental | Patients received Minoxidil (same strength as sold over the counter) twice a day for 8 weeks. Receives: Other: Minoxidil |
| Placebo | Placebo comparator | Placebo arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of change in gene expression before and after topical minoxidil application
Measured: at baseline and after 8 weeks of treatment
Differences ing ene expression in two different regions of the scalp, frontal and vertex.
Measured: Baseline and after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Pratima Karnik, Ph.D., Principal investigator, UH Case Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309191
- Sponsor's protocol ID
- 12-10-24
- Other IDs
- 338259
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2011
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Price VH. Treatment of hair loss. N Engl J Med. 1999 Sep 23;341(13):964-73. doi: 10.1056/NEJM199909233411307. No abstract available.
PubMed 10498493
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microarray Analysis of Scalp Biopsies in Subjects With Androgenetic Alopecia Before and After the Use of Topical Minoxidil
- ClinicalTrials.gov ID
- NCT01309191
- Acronym / sponsor ID
- 12-10-24
- Conditions
- Androgenetic Alopecia
- Keywords
- Androgenetic Alopecia, Minoxidil, Microarray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Kaiser Permanente
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Mar 2011 (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 determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
Detailed description
The most common type of hair loss is androgenetic alopecia (AGA), also known as male pattern balding, or hereditary thinning. In AGA, there is a gradual transformation of large terminal hair follicles to miniaturized ones under the influence of circulating androgens that produce smaller and finer hairs with a shorter anagen cycle. This transformation, which can be seen as early as the prepubescent years, occurs only in certain regions of the scalp: the frontal hairline, top and vertex scalp. The temporo-occipital region is largely unaffected even in those with extensive balding.
The first drug to be approved for the FDA for the treatment of AGA was topical minoxidil solution (TMS). Despite its successful use, the mechanism of action of TMS is not well understood. Minoxidil is a potent vasodilator and potassium channel opener, but its mechanism of action in promoting hair regrowth appears to be independent of its vasodilation properties. Improved knowledge of the changes in gene expression associated with AGA before and after treatment with TMS and compared to placebo may lead to a greater understanding of the underlying mechanisms of action of TMS. Furthermore, there is potential for identification of those patients who would best respond to or benefit from treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minoxidil | Experimental | Other: MinoxidilPatients received Minoxidil (same strength as sold over the counter) twice a day for 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo arm |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is a male
- Is in general good health
- Has a diagnosis of androgenic alopecia with hair loss in both the vertex and the frontal area, Hamilton (as modified by Norwood) Type IV-V
- Has read, signed and received a copy of the Informed Consent Form prior to initiation of the study procedures
- Is willing to follow all instructions and able to participate in the entire study, returning for all specified visits
Key exclusion criteria (39 listed)
- Evidence of concomitant skin diseases of the scalp including but not limited to dandruff, seborrheic dermatitis, psoriasis, lichenoid eruption, tinea capitis or other scalp infections or infestations.
- Has a history of recurring dandruff symptoms or seborrheic dermatitis, evidence of excoriations, or other history that might indicate an inability to use the products supplied for the duration of the study.
- Has consistently used any medicated shampoos or anti-dandruff shampoo treatment products over the past year or at all during the two months prior to the Baseline visit.
- Has a history of alopecia areata, totalis, universalis or any other hair loss disorder except male pattern baldness.
- Evidence of significant scalp scarring.
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 |
|---|---|---|
| MinoxidilAlso: RogaineOver the counter Rogaine, twice a day for 8 weeks | Other | Minoxidil |
| Placebo | Other | Placebo |
Primary outcome
Analysis of change in gene expression before and after topical minoxidil application
Time frame: at baseline and after 8 weeks of treatment
Differences ing ene expression in two different regions of the scalp, frontal and vertex.
Time frame: Baseline and after 8 weeks of treatment
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 29 Apr 2022.
- Background: PubMed 10498493Price VH. Treatment of hair loss. N Engl J Med. 1999 Sep 23;341(13):964-73. doi: 10.1056/NEJM199909233411307. No abstract available.
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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.
Pratima Karnik, Ph.D. principal investigator
UH Case Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minoxidil in people with Androgenetic Alopecia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 6 inclusion and 39 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 29 Apr 2022. 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 United States. 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?
Analysis of change in gene expression before and after topical minoxidil application (time frame: at baseline and after 8 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01309191, which also lists 1 linked publication.
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 29 Apr 2022.