Exploratory Study of Efficacy and Safety of Ingenol Mebutate 0.05% Gel for Common Warts on the Hands.

• Status: Completed
• Trial end date: 2017-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if ingenol mebutate 0.05% gel is safe and effective in treating common warts on the hands.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neal D. Bhatia, MD
• Collaborator: LEO Pharma

Criteria

Inclusion Criteria:

1. Subject is male or non-pregnant female 18 years of age or older. Females must be post-menopausal, surgically sterile, or using a medically acceptable form of birth control with a negative urine pregnancy test at Visit 1. For the purpose of this study, the following are considered medically acceptable methods of birth control: Oral Contraceptives, Contraceptive patches, Contraceptive Injection (Depo-Provera®), Contraceptive Implant (Implanon™), Essure®, Vaginal Contraceptive (Nuva-Ring®), IUD, hormonal IUD (Mirena®); double-barrier methods (e.g. condom and spermicide), sterile partner (e.g., vasectomy performed at least six months prior to the subject's initiation of treatment) and abstinence with a documented second acceptable method of birth control should subject become sexually active.

2. Subject has provided written informed consent.

3. Subject has at least two (2) verrucous papules diagnosed as common wart (verruca vulgaris) by the investigator on the hands excluding proximity to the nails (periungual warts) at Visit 1.

4. Subject is willing and able to have the investigational product (IP) applied at Visits 1 and 2, comply with study instructions and commit to all follow-up visits for the duration of the study.

5. Subject is in good general health and free of any disease state or physical condition that might impair evaluation of wart lesions or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

2. Subject is currently enrolled in an investigational drug or device study.

3. Subject has used an investigational drug or investigational device treatment within 30 days prior to the Visit 1.

4. Subject has a history of prior treatment with ingenol mebutate gel.

5. Subject is immunosuppressed (HIV, organ transplant, systemic malignancy, etc.) in the opinion of the investigator.

6. Subject has a history of injury to lesions or treatment area in the past 30 days.

7. Subject has a history of sensitivity to any of the ingredients in the investigational product.

8. Subject used any topical agents (including dry powder, bland emollients, non-medicated lotions, etc.) within a 3 cm border of the area to be treated within 14 days prior to entry into the study.

9. Subject has used topical medications such as corticosteroids, alpha-hydroxyacids greater than 5% (e.g., glycolic acid, lactic acid, etc.), beta-hydroxyacids greater than 2% (e.g., salicylic acid), urea greater than 5%, or topical retinoids (e.g., tazarotene, adapalene, tretinoin) adjacent to or within a 3 cm border around the area to be treated within 28 days prior to entry into the study.

10. Subject has used cryotherapy to lesions adjacent to or within a 3 cm border around the area to be treated within 2 weeks prior to entry into the study.

11. Subject has used systemic steroid therapy (e.g., methylprednisolone, predinisone) or NSAIDs within 7 days from Visit 1/Day 1 or initiation during the study. *Subjects may use Tylenol (Acetaminophen) for pain relief, as needed, throughout the study. Subjects may use low dose aspirin (81mg) for cardiac prophylaxis throughout the study.*

12. Subject has used chemotherapeutic agents, immunosuppressive agents, or retinoids within 4 weeks prior to entry into the study.

13. Subject has applied topical treatment such as 5-FU, imiquimod, diclofenac sodium, sinecatechins ointment, or other treatments either indicated or off-label for warts to lesions adjacent to (within a 3 cm border around the Treatment Area) or within the selected Treatment Area within 90 days prior to entry into the study.

14. Subject has had any prior intralesional treatment of the warts including injection of candida antigen, 5-FU, and bleomycin.

15. Subject has any condition in the Treatment Area that would impact the treatment or proper assessment of the outcome (e.g. scarring, marked dermatitis, etc.) in the opinion of the investigator.