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

NCT02748902 | Completed Phase 1

• 1 other identifier: TCR-202i-03-16
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Verruca Vulgaris; Common Warts

Keywords

Verruca vulgaris; Common warts; Verruca; Warts; Papilloma virus; ingenol mebutate 0.05% gel; hands

Outcome Measures

Primary Outcomes (1)

• Efficacy assessed by verruca vulgaris lesion counts (total number of lesions present)

  Total number of warts in the treatment area will be counted and assessed for clearance

  Day 1 through Day 57

Secondary Outcomes (2)

• Safety assessed by number and severity of adverse events reported

  Day 1 through Day 57

• Safety assessed by application site reactions on a 5 point scale (0/clear - 4/severe)

  Day 1 through Day 57

Study Arms (1)

ingenol mebutate 0.05% gel

EXPERIMENTAL

Single group, open label. All subjects will receive active product.

Drug: ingenol mebutate 0.05% gel

Interventions

ingenol mebutate 0.05% gel DRUG

Ingenol mebutate 0.05% gel applied to a minimum of two and a maximum of five common warts on days 1 and 2.

Also known as: Picato®

ingenol mebutate 0.05% gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject has provided written informed consent.
• 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.
• 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.
• 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.

You may not qualify if:

• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has used an investigational drug or investigational device treatment within 30 days prior to the Visit 1.
• Subject has a history of prior treatment with ingenol mebutate gel.
• Subject is immunosuppressed (HIV, organ transplant, systemic malignancy, etc.) in the opinion of the investigator.
• Subject has a history of injury to lesions or treatment area in the past 30 days.
• Subject has a history of sensitivity to any of the ingredients in the investigational product.
• 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.
• 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.
• 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.
• 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.\*
• Subject has used chemotherapeutic agents, immunosuppressive agents, or retinoids within 4 weeks prior to entry into the study.
• 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.
• Subject has had any prior intralesional treatment of the warts including injection of candida antigen, 5-FU, and bleomycin.
• 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.

Sponsors & Collaborators

• Neal D. Bhatia, MD: lead
• LEO Pharma: collaborator

Study Sites (1)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Related Publications (2)

• Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.

  PMID: 22417254 BACKGROUND

• Schopf RE. Ingenol mebutate gel is effective against anogenital warts - a case series in 17 patients. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):1041-3. doi: 10.1111/jdv.13097. Epub 2015 Mar 28. No abstract available.

  PMID: 25820019 BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

3-ingenyl angelate; Gels

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Neal D Bhatia, MD

  TCR Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Dermatology

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: April 27, 2016
• Primary Completion: January 27, 2017
• Study Completion: March 30, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)