Trial of Topical Cidofovir for the Prevention of Hair Growth
Condition: Prevention of Hair Growth
Intervention: 1% topical cidofovir; 3% topical cidofovir; Placebo
Intervention description: 1% topical cidofovir; 3% topical cidofovir; topical placebo
Intervention MeSH terms: Cidofovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be able to give informed consent.

          2. Subjects must be male, age 18 years or older.

          3. Score of 4 or 5 on the Physician's Global Assessment of Hair Density at baseline

          4. 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.

          5. 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.

          6. 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.

          7. Subjects must be willing and able to avoid exposure of the study drug to others

          8. Subjects must be able to understand and comply with drug storage and application
             procedures

        Exclusion Criteria:

          1. Use of an investigational medication 180 days prior to study enrollment (day 0).

          2. Use of topical medication that can affect hair growth during the 8 weeks prior to the
             baseline visit (e.g. minoxidil, eflornithine HCl).

          3. 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).

          4. 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.

          5. Proteinuria or hematuria upon urine analysis within two weeks of the baseline visit.

          6. 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.

          7. History of skin cancer or actinic keratoses in the treatment area.

          8. Concomitant use of any topical medication in the target areas during the study.

          9. Previous history of alopecia areata.

         10. Use of a nephrotoxic medication (tobramycin, gentamycin, amikacin, amphotericin B,
             foscarnet, vancomycin, non-steroidal anti-inflammatory agents) 7 days prior to the
             baseline visit.