Prevention of Hair GrowthPhase 2NCT00948506
Trial of Topical Cidofovir for the Prevention of Hair Growth
A Phase 2 study testing 1% topical cidofovir and 3% topical cidofovir in people with Prevention of Hair Growth, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a two-arm, single center placebo-controlled double-blind proof of concept study which will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to placebo for the prevention of hair growth. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention of Hair Growth
- What is being tested?
- 1% topical cidofovir and 3% topical cidofovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be able to give informed consent.
- Subjects must be male, age 18 years or older.
- Score of 4 or 5 on the Physician's Global Assessment of Hair Density at baseline
- Subjects must have to shave at least once a day to avoid a visible beard with a hair length that is above the skin line.
- Male subjects who are sexually active with female partners and are capable of fertilization must ensure that their female partners will either be postmenopausal, surgically incapable of childbearing, or will use a medically acceptable method of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or partner include oral contraceptives or patch, diaphragms with spermicide, IUD, condom with spermicide, or progestin implant or injection. Female partners taking oral contraceptives must have taken them consistently for at least two months prior to subject receiving study medication.
- Subjects must be able to limit the use of alcohol to 2 or fewer drinks per day for the duration of the study period. One drink corresponds to 6 oz of wine, 12 oz of beer or 1 oz of hard liquor.
- Subjects must be willing and able to avoid exposure of the study drug to others
- Subjects must be able to understand and comply with drug storage and application procedures
Who cannot join
- Use of an investigational medication 180 days prior to study enrollment (day 0).
- Use of topical medication that can affect hair growth during the 8 weeks prior to the baseline visit (e.g. minoxidil, eflornithine HCl).
- Use of a systemic medication that can affect hair growth during the 180 days prior to the baseline visit (e.g. minoxidil, cyclosporine A, finasteride).
- Clinically significant abnormality in liver function, renal function, chemistry panel or CBC (AST or ALT ≥ 2 times the laboratory's upper limit of normal, hemoglobin < 10.0 g/dL, platelet count <125,000/cm3, white blood count <3,500 cells/cm3 or > 15,000 cells/cm3, or serum creatinine ≥ 1.5 mg/dL) within two weeks of the baseline visit.
- Proteinuria or hematuria upon urine analysis within two weeks of the baseline visit.
- Active inflammatory skin disease in the treatment area (e.g. acne, cysts) or neoplasms in the treatment area that in the judgment of the investigator precludes enrollment.
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- History of skin cancer or actinic keratoses in the treatment area.
- Concomitant use of any topical medication in the target areas during the study.
- Previous history of alopecia areata.
- Use of a nephrotoxic medication (tobramycin, gentamycin, amikacin, amphotericin B, foscarnet, vancomycin, non-steroidal anti-inflammatory agents) 7 days prior to the baseline visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of PA
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Single-center Proof of Concept Study of Topical Cidofovir for the Prevention of Hair Growth
This is a two-arm, single center placebo-controlled double-blind proof of concept study which will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to placebo for the prevention of hair growth.
Read the detailed description
This is a phase II randomized, placebo controlled double blind, dose-ranging clinical trial of topical cidofovir for the prevention of hair growth. This proof of concept study will evaluate 1% and 3% cidofovir in petrolatum topically applied once a day to the target treatment area on the hair bearing area of the face known as the beard area. This target area will be of a circular shape with a diameter of three centimeters along the jaw line of one side of the face.The first 14 enrolled subjects in the study will be randomized in a 1:1 fashion to receive either 1% topical cidofovir and placebo or 3% topical cidofovir and placebo. The last cohort of subjects to be enrolled in the study to achieve a total of 16 evaluable subjects will all receive the 3% formulation and placebo. Subjects will also be randomized as to which side of their face (left or right) will receive active drug versus placebo.
Subjects will be treated for up to eight weeks. Any subject who achieves 100% alopecia (which corresponds to a 0 on the PGA of Hair Density) in the treated area prior to eight weeks will be classified as a responder and will discontinue active treatment and begin the four week observation period. From the time of discontinuing treatment, subjects will be followed for four weeks during which time safety data will be collected.
- Conditions
- Prevention of Hair Growth
- Being tested
- 1% topical cidofovir, 3% topical cidofovir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% topical cidofovirDrug
Also called Vistide
1% topical cidofovir
3% topical cidofovirDrug
Also called Vistide
3% topical cidofovir
PlaceboDrug
topical placebo
| Study group | Role | What they receive |
|---|---|---|
| 1% topical cidofovir | Placebo comparator | 1% topical cidofovir to one side of the face and placebo to the other side of the face Receives: Drug: 1% topical cidofovir; Drug: Placebo |
| 3% topical cidofovir | Placebo comparator | 3% topical cidofovir to one side of the face and placebo to the other side of the face Receives: Drug: 3% topical cidofovir; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment (PGA) of Hair Density
Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).
Measured: up to 8 weeks or end of active treatment
Secondary outcomes (1)
Subject-reported Adverse Events or Abnormal Findings
Number of participants who reported an adverse event (as assessed by subject interview and if indicated, physical exam) or had abnormal finding on urine and blood laboratory examination
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prevention of Hair GrowthStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel M Gelfand, MD, MSCE, Principal investigator, Hospital of the University of PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948506
- Sponsor's protocol ID
- 809821
- Status last verified
- Mar 2012
- First submitted
- 23 Jul 2009
- Last updated
- 19 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Single-center Proof of Concept Study of Topical Cidofovir for the Prevention of Hair Growth
- ClinicalTrials.gov ID
- NCT00948506
- Acronym / sponsor ID
- 809821
- Conditions
- Prevention of Hair Growth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Posted 24 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-arm, single center placebo-controlled double-blind proof of concept study which will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to placebo for the prevention of hair growth.
Detailed description
This is a phase II randomized, placebo controlled double blind, dose-ranging clinical trial of topical cidofovir for the prevention of hair growth. This proof of concept study will evaluate 1% and 3% cidofovir in petrolatum topically applied once a day to the target treatment area on the hair bearing area of the face known as the beard area. This target area will be of a circular shape with a diameter of three centimeters along the jaw line of one side of the face.The first 14 enrolled subjects in the study will be randomized in a 1:1 fashion to receive either 1% topical cidofovir and placebo or 3% topical cidofovir and placebo. The last cohort of subjects to be enrolled in the study to achieve a total of 16 evaluable subjects will all receive the 3% formulation and placebo. Subjects will also be randomized as to which side of their face (left or right) will receive active drug versus placebo.
Subjects will be treated for up to eight weeks. Any subject who achieves 100% alopecia (which corresponds to a 0 on the PGA of Hair Density) in the treated area prior to eight weeks will be classified as a responder and will discontinue active treatment and begin the four week observation period. From the time of discontinuing treatment, subjects will be followed for four weeks during which time safety data will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% topical cidofovir | Placebo comparator | Drug: 1% topical cidofovir, Drug: Placebo1% topical cidofovir to one side of the face and placebo to the other side of the face |
| 3% topical cidofovir | Placebo comparator | Drug: 3% topical cidofovir, Drug: Placebo3% topical cidofovir to one side of the face and placebo to the other side of the face |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be able to give informed consent.
- Subjects must be male, age 18 years or older.
- Score of 4 or 5 on the Physician's Global Assessment of Hair Density at baseline
- Subjects must have to shave at least once a day to avoid a visible beard with a hair length that is above the skin line.
- Male subjects who are sexually active with female partners and are capable of fertilization must ensure that their female partners will either be postmenopausal, surgically incapable of childbearing, or will use a medically acceptable method of contraception throughout the entire study period. Medically acceptable methods of contraception that may be used by the subject and/or partner include oral contraceptives or patch, diaphragms with spermicide, IUD, condom with spermicide, or progestin implant or injection. Female partners taking oral contraceptives must have taken them consistently for at least two months prior to subject receiving study medication.
Key exclusion criteria (10 listed)
- Use of an investigational medication 180 days prior to study enrollment (day 0).
- Use of topical medication that can affect hair growth during the 8 weeks prior to the baseline visit (e.g. minoxidil, eflornithine HCl).
- Use of a systemic medication that can affect hair growth during the 180 days prior to the baseline visit (e.g. minoxidil, cyclosporine A, finasteride).
- Clinically significant abnormality in liver function, renal function, chemistry panel or CBC (AST or ALT ≥ 2 times the laboratory's upper limit of normal, hemoglobin < 10.0 g/dL, platelet count <125,000/cm3, white blood count <3,500 cells/cm3 or > 15,000 cells/cm3, or serum creatinine ≥ 1.5 mg/dL) within two weeks of the baseline visit.
- Proteinuria or hematuria upon urine analysis within two weeks of the baseline visit.
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 |
|---|---|---|
| 1% topical cidofovirAlso: Vistide1% topical cidofovir | Drug | 1% topical cidofovir |
| 3% topical cidofovirAlso: Vistide3% topical cidofovir | Drug | 3% topical cidofovir |
| Placebotopical placebo | Drug | 1% topical cidofovir, 3% topical cidofovir |
Primary outcome
Physician's Global Assessment (PGA) of Hair Density
Time frame: up to 8 weeks or end of active treatment
Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).
1 secondary outcome
Subject-reported Adverse Events or Abnormal Findings
Time frame: up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Joel M Gelfand, MD, MSCE principal investigator
Hospital of the University of PA
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 1% topical cidofovir and 3% topical cidofovir in people with Prevention of Hair Growth, run by University of Pennsylvania 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 8 inclusion and 10 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 19 Mar 2012. 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.
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?
Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physician's Global Assessment (PGA) of Hair Density (time frame: up to 8 weeks or end of active treatment). 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 19 Mar 2012.