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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% topical cidofovir | Placebo Comparator | 1% topical cidofovir to one side of the face and placebo to the other side of the face |
|
| 3% topical cidofovir | Placebo Comparator | 3% topical cidofovir to one side of the face and placebo to the other side of the face |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% topical cidofovir | Drug | 1% topical cidofovir |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 8 weeks or end of active treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel M Gelfand, MD, MSCE | Hospital of the University of PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of PA | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Cidofovir and Placebo | Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design. |
| FG001 | 3% Cidofovir and Placebo | Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Cidofovir and Placebo | Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design. |
| BG001 | 3% Cidofovir and Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The analysis was performed using intention-to-treat and all enrolled participants who received treatment were included in the analysis. For participants who withdrew during treatment, the data from their last visit were carried forward. | Posted | Number | participants | up to 8 weeks or end of active treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1% Cidofovir and Placebo | Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal bleeding | Gastrointestinal disorders | Non-systematic Assessment | Participant self-reported an episode of gastrointestinal bleeding resulting in hospitalization but no documentation of the hospitalization was received. The IRB was notified. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy Wan | University of Pennsylvania | 2157466364 | joy.wan@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D000077404 | Cidofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003596 | Cytosine |
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| 3% topical cidofovir | Drug | 3% topical cidofovir |
|
|
| Placebo | Drug | topical placebo |
|
Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 3% Cidofovir |
Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face). |
| OG002 | Placebo | Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face). |
|
|
| Secondary | 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 | The analysis was performed using intention-to-treat, whereby all enrolled participants who received treatment were analyzed. | Posted | Number | participants | up to 16 weeks |
|
|
|
| 1 |
| 11 |
| 6 |
| 11 |
| EG001 | 3% Cidofovir and Placebo | Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design. | 0 | 9 | 6 | 9 |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Erythema of the treatment area | Skin and subcutaneous tissue disorders | Systematic Assessment | Erythema - in 1 subject on the 3% cidofovir-treated side; in 2 subjects on the 1% cidofovir-treated side |
|
| Pruritis of treatment area | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Pruritis - in 1 subject on the 3% cidofovir-treated side; in 1 subject on both the 1% cidofovir-treated and placebo-treated sides |
|
| Cold sores | Infections and infestations | Non-systematic Assessment |
|
| Rash over the untreated area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin tenderness of untreated area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Eyelid twitch | Nervous system disorders | Non-systematic Assessment |
|
| Flare of pre-existing brachial neuritis | Nervous system disorders | Non-systematic Assessment |
|
| Dog bite | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Toothache after a dental procedures | Surgical and medical procedures | Non-systematic Assessment |
|
| Neck swelling after surgical nerve block | Surgical and medical procedures | Non-systematic Assessment |
|
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| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |