Trial of Topical Cidofovir for the Prevention of Hair Growth

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Cidofovir

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.