Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp

NCT02406014 | Completed Phase 4

• 1 other identifier: LP0041-1120
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.

Conditions

Actinic Keratosis (AK)

Outcome Measures

Primary Outcomes (1)

• Complete clearance of all AKs

  Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%

  11 Months

Secondary Outcomes (1)

• Complete clearance of all AKs at Week 17

  11 Months

Study Arms (2)

Treatment Group A

ACTIVE COMPARATOR

Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.

Drug: Ingenol Mebutate Gel, 0.015%

Treatment Group B

ACTIVE COMPARATOR

Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Drug: Diclofenac sodium gel 3%

Interventions

Ingenol Mebutate Gel, 0.015% DRUG

Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.

Also known as: Picato®

Treatment Group A

Diclofenac sodium gel 3% DRUG

Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days.

Also known as: Solaraze®

Treatment Group B

Eligibility Criteria

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

You may qualify if:

• Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
• Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp

You may not qualify if:

• \. Location of the selected treatment area:
• on the periorbital skin
• on the perioral skin/around the nostrils
• within 5 cm of an incompletely healed wound
• within 10 cm of a suspected BCC or SCC or other neoplasia

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Gemain, Weber & Craninic

Schweinfurt, 97421, Germany

Location

Related Publications (1)

• Stockfleth E, Harwood CA, Serra-Guillen C, Larsson T, Osterdal ML, Skov T. Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp. Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15.

  PMID: 29030864 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate; Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Eggert Stockfleth, Prof.Dr.med.

  St. Josef-Hospital im Katholischen Klinikum Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 1, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 24, 2025

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)