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

Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
MedDRA version: 14.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Actinic Keratosis

Registration Number: EUCTR2012-002863-88-IT

Lead Sponsor: EO PHARMA A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. 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.
2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within
a contiguous 25 cm2 treatment area on face or scalp.
3. Subjects with 4 to 8 clinically typical, visible and discrete AKs within
a contiguous 25 cm2 treatment area on trunk or extremities.
4. Subject at least 18 years of age.
5. Female subjects must be of either:
a. Non-childbearing potential, i.e. post-menopausal or have a confirmed
clinical history of sterility (e.g. the subject is without a uterus) or,
b. Childbearing potential, provided there is a confirmed negative urine
pregnancy test prior to trial treatment, to rule out pregnancy.
6. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
Effective contraception is defined as follows:
- Oral/implant/injectable/transdermal/oestrogenic vaginal ring
contraceptives, intrauterine device, condom with spermicide, diaphragm
with spermicide.
- Abstinence or partner's vasectomy are acceptable if the female agrees
to implement one of the other acceptable methods of birth control if her
partner changes.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. 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).
2. Prior treatment with ingenol mebutate gel on face/scalp and on
trunk/extremities.
3. Lesions in the selected treatment areas that have:
• atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or
cutaneous horns) and/or,
• recalcitrant disease (e.g., did not respond to cryotherapy on two
previous occasions).
4. History or evidence of skin conditions other than the trial indication
that would interfere with the evaluation of the trial medication (e.g.,
eczema, unstable psoriasis, xeroderma pigmentosum).
5. Use of cosmetic or therapeutic products and procedures which could
interfere with the assessments of the selected treatment areas.
6. 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.
7. Anticipated need for hospitalisation or out-patient surgery during the
first 15 days after the first trial medication application. Note that
cosmetic/therapeutic procedures are not excluded if they fall outside of
the criteria detailed in Prohibited Therapies or Medications (see
Exclusion Criteria Nos. 14-21).
8. Known sensitivity or allergy to any of the ingredients in ingenol
mebutate gel.
9. Presence of sunburn within the selected treatment areas.
10. Current enrolment or participation in an investigational clinical trial
within 30 days of entry into this trial.
11. Subjects previously randomised in the trial.
12. Female subjects who are breastfeeding.
13. In the opinion of the investigator, the subject is unlikely to comply
with the Clinical Study Protocol (e.g. alcoholism, drug dependency or
psychotic state).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To determine the efficacy and treatment satisfaction of a simultaneous<br>treatment regimen compared to a sequential treatment regimen when<br>two separate areas with AKs (one located on face or scalp and the other<br>located on trunk or extremities) are treated with ingenol mebutate gel.;Main Objective: To evaluate the safety of a simultaneous treatment regimen compared to<br>a sequential treatment regimen when two separate areas with AKs (one<br>located on face or scalp and the other located on trunk or extremities)<br>are treated with ingenol mebutate gel.<br>The primary response criterion is the composite Local Skin Reaction<br>(LSR) score 3 days after treatment start of each selected treatment area.;Primary end point(s): Composite LSR score 3 days after treatment start of each selected<br>treatment area;Timepoint(s) of evaluation of this end point: 3 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • TSQM after a treatment cycle of 8 weeks,<br>• Complete clearance of AKs in each separate treatment area 8 weeks<br>after treatment,<br>• Partial clearance of AKs in each separate treatment area 8 weeks<br>after treatment, defined as 75% or greater reduction in AKs from start of<br>treatment to 8 weeks after treatment,<br>• Percent reduction in number of AKs in each separate treatment area 8<br>weeks after treatment.;Timepoint(s) of evaluation of this end point: 8 weeks

Related Trials