Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis

NCT02716714 | Completed Phase 4 Results DMC

• 1 other identifier: KSSCLK2014-01
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp \& 0.05% on trunk and extremities in Korean patient with actinic keratosis.

Conditions

Actinic Keratosis

Keywords

Korean

Outcome Measures

Primary Outcomes (1)

• CC Rate of AK Lesions in the Selected Treatment Area

  Complete Clearance (CC) means that clearance of all visible AK lesions in the selected treatment area and Investigator-rated actinic keratiosis(AK) lesion complete clearance (CC) rate at the selected treatment area on day 57 was analyzed.

  at day 57

Secondary Outcomes (8)

• Percentage Change of the Number of AK Lesions in the Selected Treatment Area

  Baseline and Day 57

• Sustained CC Rate in CC Group

  at 6 months

• Recurrence Rate in CC Group

  at 6 months

• Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group

  at 6 months from baseline

• Change From Baseline in Quality of Life (Skindex-29)

  at 29 and 57 days from baseline

Other Outcomes (2)

• Medication for Actinic Keratosis

  from 57 days to 6 months

• Non-Drug Treatment/Surgery for Actinic Keratosis

  from 57 days to 6 months

Study Arms (2)

ingenol mebutate gel 0.015%

ACTIVE COMPARATOR

Applied on face and scalp for three days.

Drug: ingenol mebutate gel 0.015%

ingenol mebutate gel 0.05%

ACTIVE COMPARATOR

Applied on trunk and extremities for two days.

Drug: ingenol mebutate gel 0.05%

Interventions

ingenol mebutate gel 0.015% DRUG

-Face or Scalp arm (Referred to Face/Scalp arm): Apply ingenol mebutate gel 0.015% once daily for 3 consecutive days

Also known as: Picato® gel

ingenol mebutate gel 0.015%

ingenol mebutate gel 0.05% DRUG

-Trunk or Extremities arm (Referred to Trunk/Extremities arm): Apply ingenol mebutate gel 0.05% once daily for 2 consecutive days

Also known as: Picato® gel

ingenol mebutate gel 0.05%

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 19 years
• Histopathologically diagnosed AK patients with at least 1 macroscopic and discrete lesion within a contiguous 25 cm2 (e.g. 5 cm x 5 cm) of treatment area
• The treatment area including the lesion must be accessible to apply the investigational product. However, the lesions on lips, mucosa, outer ear (concha) and those around eyes are excluded.
• Subjects who signed the written informed consent prior to perform any study-related procedures or assessments, including photographs of their treatment area for documentation and efficacy assessment.

You may not qualify if:

• Hypersensitivity to any components of the investigational product
• History or evidence of skin conditions that could interfere with evaluation of the investigational product(e.g., eczema, unstable psoriasis, xeroderma pigmentosa, inflammatory or infectious disease around the selected treatment area)
• Unhealed wound within 5 cm, or basal cell carcinoma or squamous cell carcinoma within 10 cm from the selected treatment area.
• Subjects who received or expected to receive any of the following pharmacotherapy and non-pharmacotherapy or procedures during the treatment and follow-up period
• Subjects who have following disorder or abnormal laboratory result
• Pregnant, lactating, and childbearing potential women who are unwilling to practice effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and abstinence.
• Subjects who previously underwent another clinical trial within 30 days or 5-times the half-life of previous investigational product prior to baseline (the longer period of time must be considered).
• Other conditions by investigator's discretion to be inappropriate for this clinical study.

Sponsors & Collaborators

• Korea University: lead
• LEO Pharma: collaborator
• Chonnam National University Hospital: collaborator
• Severance Hospital: collaborator
• Ajou University School of Medicine: collaborator
• Asan Medical Center: collaborator
• Samsung Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator
• Dong-A University Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Seoul National University Hospital: collaborator

Study Sites (1)

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Related Publications (16)

• Callen JP, Bickers DR, Moy RL. Actinic keratoses. J Am Acad Dermatol. 1997 Apr;36(4):650-3. doi: 10.1016/s0190-9622(97)70265-2. No abstract available.

  PMID: 9092763 RESULT

• Schmitt JV, Miot HA. Actinic keratosis: a clinical and epidemiological revision. An Bras Dermatol. 2012 May-Jun;87(3):425-34. doi: 10.1590/s0365-05962012000300012.

  PMID: 22714759 RESULT

• Brash DE, Ziegler A, Jonason AS, Simon JA, Kunala S, Leffell DJ. Sunlight and sunburn in human skin cancer: p53, apoptosis, and tumor promotion. J Investig Dermatol Symp Proc. 1996 Apr;1(2):136-42.

  PMID: 9627707 RESULT

• Flohil SC, van der Leest RJ, Dowlatshahi EA, Hofman A, de Vries E, Nijsten T. Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study. J Invest Dermatol. 2013 Aug;133(8):1971-8. doi: 10.1038/jid.2013.134. Epub 2013 Mar 19.

  PMID: 23510990 RESULT

• Rossi R, Mori M, Lotti T. Actinic keratosis. Int J Dermatol. 2007 Sep;46(9):895-904. doi: 10.1111/j.1365-4632.2007.03166.x. No abstract available.

  PMID: 17822489 RESULT

• Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):4-7. doi: 10.1067/mjd.2000.103342.

  PMID: 10607349 RESULT

• Kim HS, Cho EA, Bae JM, Yu DS, Oh ST, Kang H, Park CJ, Lee JD, Lee JY, Kim SY, Kim HO, Park YM. Recent trend in the incidence of premalignant and malignant skin lesions in Korea between 1991 and 2006. J Korean Med Sci. 2010 Jun;25(6):924-9. doi: 10.3346/jkms.2010.25.6.924. Epub 2010 May 24.

  PMID: 20514316 RESULT

• Slaper H, Velders GJ, Daniel JS, de Gruijl FR, van der Leun JC. Estimates of ozone depletion and skin cancer incidence to examine the Vienna Convention achievements. Nature. 1996 Nov 21;384(6606):256-8. doi: 10.1038/384256a0.

  PMID: 8918873 RESULT

• Nelson CG. Diclofenac gel in the treatment of actinic keratoses. Ther Clin Risk Manag. 2011;7:207-11. doi: 10.2147/TCRM.S12498. Epub 2011 Jun 15.

  PMID: 21753882 RESULT

• Stockfleth E, Ferrandiz C, Grob JJ, Leigh I, Pehamberger H, Kerl H; European Skin Academy. Development of a treatment algorithm for actinic keratoses: a European Consensus. Eur J Dermatol. 2008 Nov-Dec;18(6):651-9. doi: 10.1684/ejd.2008.0514. Epub 2008 Oct 27.

  PMID: 18955209 RESULT

• Anderson L, Schmieder GJ, Werschler WP, Tschen EH, Ling MR, Stough DB, Katsamas J. Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. J Am Acad Dermatol. 2009 Jun;60(6):934-43. doi: 10.1016/j.jaad.2009.01.008.

  PMID: 19467365 RESULT

• Vegter S, Tolley K. A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe. PLoS One. 2014 Jun 3;9(6):e96829. doi: 10.1371/journal.pone.0096829. eCollection 2014.

  PMID: 24892649 RESULT

• Lebwohl M, Dinehart S, Whiting D, Lee PK, Tawfik N, Jorizzo J, Lee JH, Fox TL. Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials. J Am Acad Dermatol. 2004 May;50(5):714-21. doi: 10.1016/j.jaad.2003.12.010.

  PMID: 15097955 RESULT

• Rosen RH, Gupta AK, Tyring SK. Dual mechanism of action of ingenol mebutate gel for topical treatment of actinic keratoses: rapid lesion necrosis followed by lesion-specific immune response. J Am Acad Dermatol. 2012 Mar;66(3):486-93. doi: 10.1016/j.jaad.2010.12.038. Epub 2011 Nov 4.

  PMID: 22055282 RESULT

• 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 RESULT

• Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.

  PMID: 23553119 RESULT

Related Links

• National Institute for Clinical Excellence. Guidance on Cancer Services:Improving outcomes for people with skin tumours including melanoma. The manual. February 2006.

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ilhwan Kim
• Organization: Korea University Ansan Hospital

kumcihk@korea.ac.kr

+82314125986

Study Officials

• Ilhwan Kim, MD

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: March 23, 2016
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 18, 2018
• Results First Posted: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)