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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748902
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Neal D. Bhatia, MD, TCR Medical Corporation

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.

Condition or disease Intervention/treatment Phase
Verruca Vulgaris Common Warts Drug: ingenol mebutate 0.05% gel Phase 1

Detailed Description:

This is an open label exploratory study evaluating the efficacy and safety of ingenol mebutate 0.05% gel for the treatment of verruca vulgaris. The study will be conducted at one site with one investigator, all subjects will receive active drug. Prior to the application of the investigational product (IP) on Day 1, the individual warts will be pared down with a 15 blade up to obtain debridement of intact skin to maximize exposure and allow for effective penetration of therapy into the lesion.

Subjects can be screened for the study up to 45 days before Visit 1. During screening, the study requirements will be reviewed, written informed consent obtained, and eligibility confirmed. If applicable, qualified subjects can washout from prohibited medications or treatments prior to Visit 1 once they have been consented. These procedures may be combined with Visit 1.

There will be one treatment arm, all subjects receive active ingenol mebutate 0.05% gel once daily for two consecutive days to lesions. Each subject will be screened for inclusion. The treatment will be applied to the entire wart lesion(s) and 0.5 cm margin around the lesion(s). All treatments will be applied in the clinic. A minimum of two (2) and a maximum of five (5) warts will be treated. In addition, one of the two warts will be identified for treatment with occlusion with a bandage each day for 24 hours after each application.

The subjects will be evaluated at Day 1 and Day 2 when the consecutive applications of investigational product will be applied, then at Day 8, 29 and 57 to evaluate anticipated efficacy outcomes (lesion size, clearance, etc.) as well as assess for adverse events/SAEs. The wart that is identified for occlusion will be treated with investigational product and occluded for 24 hours after each application of IP. Subjects will be instructed to avoid excessive exposures to water or other potential contactants or irritants after application of the IP for the following 48 hours to avoid transfer of the IP.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Exploratory Study Evaluating the Efficacy and Safety of Ingenol Mebutate 0.05% Gel for the Treatment of Verruca Vulgaris.
Actual Study Start Date : April 27, 2016
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: ingenol mebutate 0.05% gel
Single group, open label. All subjects will receive active product.
Drug: ingenol mebutate 0.05% gel
Ingenol mebutate 0.05% gel applied to a minimum of two and a maximum of five common warts on days 1 and 2.
Other Name: Picato®




Primary Outcome Measures :
  1. Efficacy assessed by verruca vulgaris lesion counts (total number of lesions present) [ Time Frame: Day 1 through Day 57 ]
    Total number of warts in the treatment area will be counted and assessed for clearance


Secondary Outcome Measures :
  1. Safety assessed by number and severity of adverse events reported [ Time Frame: Day 1 through Day 57 ]
    All adverse events that occur during the study (from the time of informed consent) will be recorded.

  2. Safety assessed by application site reactions on a 5 point scale (0/clear - 4/severe) [ Time Frame: Day 1 through Day 57 ]
    Application site reactions defined as of erythema, flaking/scaling, crusting, swelling, erosion/ulceration and vesiculation/pustulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748902


Locations
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United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
Sponsors and Collaborators
Neal D. Bhatia, MD
LEO Pharma
Investigators
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Principal Investigator: Neal D Bhatia, MD TCR Medical Corporation
Publications:
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Responsible Party: Neal D. Bhatia, MD, Director, Clinical Dermatology, TCR Medical Corporation
ClinicalTrials.gov Identifier: NCT02748902    
Other Study ID Numbers: TCR-202i-03-16
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data will be collected and reported in aggregate through peer reviewed journal publication and/or poster presentations.
Keywords provided by Neal D. Bhatia, MD, TCR Medical Corporation:
Verruca vulgaris
Common warts
Verruca
Warts
Papilloma virus
ingenol mebutate 0.05% gel
hands
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases