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Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%

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: NCT02446223
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Goldman, Butterwick, Fitzpatrick and Groff

Brief Summary:
Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Inggenol Mebutate 0.015% Phase 4

Detailed Description:

This will be an open-label study to evaluate the efficacy and safety of ingenol mebutate gel, 0.015% used in topical therapy of actinic keratosis on the chest. Subjects that present with 4 or more actinic keratosis in one continuous 100cm2 area of the chest and meet all inclusion/exclusion criteria will be enrolled into this study.

Treatment with the investigational product (IP) will be applied for three continuous days. The investigator will guide application of the IP in-office at Day 0 and the subject will be instructed to self-administer the IP at Days 1 and 2. Follow-up visits will be scheduled at Days 1, 3, 10, 17, 24 and 59.

Prior to treatment and at each visit, the investigator will assess the subject's treatment area for lesion counts and at follow up visits 4, 5, 6 and 7 evaluation of clearance. Pre-treatment photography will also be collected at baseline and at each follow up visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Prospective Clinical Trial to Evaluate the Efficacy and Safety of Large-Scale, Field-Directed Topical Therapy of Actinic Keratosis of the Chest With Ingenol Mebutate 0.015%
Study Start Date : January 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Active Drug: Inggenol Mebutate 0.015%



Primary Outcome Measures :
  1. Change in Lesion Count From Baseline to Day 59 [ Time Frame: Day 59 ]
    The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions.



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. Male or female of at least 18 years of age.
  2. Subjects willing to comply with study requirements.
  3. The presence of four or more clinically typical actinic keratosis within one contiguous area of the chest that is 100cm2.
  4. For female subjects of childbearing potential willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use at least 30 days prior to entry into the study.

    A female is considered NOT to be of childbearing potential if she is postmenopausal for at least one (1) year, without a uterus, without both ovaries or has had a bilateral tubal ligation.

    Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants Norplant, Depo-Provera, double-barrier methods (e.g. condoms and spermicide) and abstinence.

  5. Subjects willing to refrain from the use of topical products containing alpha-hydroxy acids, retinoic acid, retinol, salicylic acid, and vitamins C/D (or their derivatives) in the treatment area 7 Days prior to and during the entire study period

Exclusion Criteria:

  1. Known hypersensitivity, prior allergic reaction, or prior chest treatment with ingenol mebutate gel.
  2. Treatment area containing hypertrophic or hyperkeratotic lesions, cutaneous horns or lesions that had previously not responded to other standard treatments.
  3. Presence of any skin condition or disease that might interfere with the diagnosis and evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis).
  4. Subjects receiving ablative laser treatments on their chest must have discontinued the treatment at least 6 months prior to entering the study.
  5. Subjects receiving Intense Pulse Light treatments on their chest must have discontinued the treatment at least 30 days prior to entering the study.
  6. Within 3 months of study entry treatments that may interfere with evaluation of the treatment area (e.g. other topical therapies for actinic keratosis of the chest, topical corticosteroids, topical retinoids, ultraviolet B phototherapy, or immunosuppressive, immunomodulating, or cytotoxic medications) or expected use of any of the above-mentioned therapies in the treatment area listed during the duration of the study.
  7. Within 3 months of study entry topical treatment in the treatment area for actinic keratosis including, but not limited to imiquimond, 5- fluorouracil, diclofenac or liquid nitrogen.
  8. Within 6 months of study entry treatments with Poly-L-lactic acid (PLLA; Sculptra Aesthetic) that may interfere with the evaluation of the treatment area.
  9. Within 7 days of study entry use of self-tanners, excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of any listed during the time of the study within the treatment area.
  10. Any systemic disease that is not yet stabilized for at least six (6) Months prior to entering study.
  11. A significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would interfere with the objectives of the study
  12. Pregnant or nursing women or women planning a pregnancy during the study period.
  13. Any unhealed skin lesions or wounds within the treatment area.
  14. Existence of one (1) or more suspected basal cell carcinoma or squamous cell carcinoma within the treatment area.
  15. Current participation or participation within 30 days prior to the start of this study in a drug or investigational device research study.

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): NCT02446223


Locations
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United States, California
Cosmetic Laser Dermatology
San Diego, California, United States, 92121
Sponsors and Collaborators
Goldman, Butterwick, Fitzpatrick and Groff
LEO Pharma
Investigators
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Principal Investigator: Mitchel P Goldman, MD Cosmetic Laser Dermatology
  Study Documents (Full-Text)

Documents provided by Goldman, Butterwick, Fitzpatrick and Groff:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier: NCT02446223    
Other Study ID Numbers: PICATO-2013-01
First Posted: May 18, 2015    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: August 2019
Keywords provided by Goldman, Butterwick, Fitzpatrick and Groff:
Actinic Keratosis AKs Chest Pre-Cancer
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms