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

NCT02446223 | Completed Phase 4 Results

• 1 other identifier: PICATO-2013-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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%

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis AKs Chest Pre-Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Active

EXPERIMENTAL

Drug: Inggenol Mebutate 0.015%

Interventions

Inggenol Mebutate 0.015% DRUG

Active

Eligibility Criteria

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

You may qualify if:

• Male or female of at least 18 years of age.
• Subjects willing to comply with study requirements.
• The presence of four or more clinically typical actinic keratosis within one contiguous area of the chest that is 100cm2.
• 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.
• 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

You may not qualify if:

• Known hypersensitivity, prior allergic reaction, or prior chest treatment with ingenol mebutate gel.
• Treatment area containing hypertrophic or hyperkeratotic lesions, cutaneous horns or lesions that had previously not responded to other standard treatments.
• 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).
• Subjects receiving ablative laser treatments on their chest must have discontinued the treatment at least 6 months prior to entering the study.
• Subjects receiving Intense Pulse Light treatments on their chest must have discontinued the treatment at least 30 days prior to entering the study.
• 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.
• 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.
• 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.
• 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.
• Any systemic disease that is not yet stabilized for at least six (6) Months prior to entering study.
• 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
• Pregnant or nursing women or women planning a pregnancy during the study period.
• Any unhealed skin lesions or wounds within the treatment area.
• Existence of one (1) or more suspected basal cell carcinoma or squamous cell carcinoma within the treatment area.
• Current participation or participation within 30 days prior to the start of this study in a drug or investigational device research study.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• LEO Pharma: collaborator

Study Sites (1)

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

Related Publications (1)

• 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.

  PMID: 28979661 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Cosmetic Laser Dermatology/West Dermatology Research

IGuiha@CLderm.com

858 657 1004

Study Officials

• Mitchel P Goldman, MD

  Cosmetic Laser Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 18, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

US (1)