A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

NCT01787383 | Completed Phase 3 Results

• 2 other identifiers: LP0041-642012-002863-88
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; Ingenol mebutate gel

Outcome Measures

Primary Outcomes (1)

• Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area

  Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together "Per Arm". Each subject could contribute with up to 2 values (1 for each treated area).

  3 days after treatment of each selected treatment area

Secondary Outcomes (7)

• Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment

  8 weeks after treatment

• Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment

  8 weeks after treatment

• Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment

  8 weeks after treatment

• Effectiveness Satisfaction Questionnaire for Medication (TSQM)

  8 weeks

• Side Effects TSQM

  8 weeks

Study Arms (2)

Ingenol mebutate gel 0.05 %

ACTIVE COMPARATOR

Drug: Ingenol mebutate gel 0.05 %; Drug: Ingenol mebutate gel 0.015 %

Ingenol mebutate gel 0.015 %

ACTIVE COMPARATOR

Drug: Ingenol mebutate gel 0.05 %; Drug: Ingenol mebutate gel 0.015 %

Interventions

Ingenol mebutate gel 0.05 % DRUG

Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially

Also known as: Picato®

Ingenol mebutate gel 0.015 %; Ingenol mebutate gel 0.05 %

Ingenol mebutate gel 0.015 % DRUG

Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially

Also known as: Picato®

Ingenol mebutate gel 0.015 %; Ingenol mebutate gel 0.05 %

Eligibility Criteria

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

You may qualify if:

• Subjects must provide informed consent
• Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on face or scalp
• Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities
• Subjects at least 18 years of age
• Female subjects must be of either:
• Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
• Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.
• Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

You may not qualify if:

• Location of the selected treatment areas:
• on the periorbital skin
• within 5 cm of an incompletely healed wound
• within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
• Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities
• Lesions in the selected treatment areas that have:
• atypical clinical appearance (and/or,
• recalcitrant disease
• History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication
• Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas
• Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment.
• Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application.
• Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
• Presence of sunburn within the selected treatment areas
• Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Clinica Dermatologica dell'Università di Modena e Reggio Emilia

Modena, 41124, Italy

Location

Related Publications (1)

• Pellacani G, Peris K, Guillen C, Clonier F, Larsson T, Venkata R, Puig S. A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body. J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2192-8. doi: 10.1111/jdv.13211. Epub 2015 Aug 24.

  PMID: 26300464 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical trial disclosure manager
• Organization: LEO Pharma A/S

ctr.disclosure@leopharma.com

00 45 44 94 58 88

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 24, 2025
• Results First Posted: May 7, 2015

Record last verified: 2021-05

Locations

IT (1)