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

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%

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

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: Inggenol Mebutate 0.015%

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Cosmetic Laser Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active	Drug: Inggenol Mebutate 0.015%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lesion Count From Baseline to 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.	Day 59

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: LEO Pharma

Publications and helpful links

General Publications

• Wu DC, Guiha I, Goldman MP. A Prospective Pilot Clinical Trial to Evaluate the Efficacy and Safety of Topical Therapy with Ingenol Mebutate Gel 0.015% for Actinic Keratosis on an Expanded Area of the Chest. J Clin Aesthet Dermatol. 2017 Aug;10(8):31-36. Epub 2017 Aug 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Actinic Keratosis AKs Chest Pre-Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: PICATO-2013-01