Study to compare the Metvix® efficacy in eliminating the actinic (solar) keratoses when activated by the natural daylight or by a red lamp

Conditions: Mild and/or moderate Actinic Keratoses
MedDRA version: 14.1Level: HLTClassification code 10020648Term: HyperkeratosesSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2013-000973-54-SE

Lead Sponsor: Galderma R&D SNC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

- Male or female, who is at least 18 years of age or older,
- Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas (TAs) according to Olsen et al scale (1991). (e.g.: thin and/or non-hyperkeratotic AKs),
- Subject with two symmetrical TAs (either two half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs
- TA comparable in terms of size: 6 by 16 cm at a maximum
- A minimum of 5 AKs (either mild, moderate or both) per TA
- No more than two lesions difference in number of moderate AKs between the two TAs.
- Female of non-childbearing potential, OR female of childbearing potential with a negative urine pregnancy test (UPT).
- If female of childbearing potential, they should:
- have been strictly abstinent 1 month prior to Baseline and agrees to remain abstinent for the duration of the clinical trial,
- and/or agree to use a highly effective and approved contraceptive method(s) during the duration of the clinical trial (bilateral tubal ligation OR combined oral contraceptives (oestrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to Baseline OR vasectomized partner for at least 3 months prior to Baseline OR hormonal intra uterine device (IUD) inserted at least 1 month prior to Baseline.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Subject with clinical diagnosis of at least one severe (Grade 3) AK on TAs according to Olsen et al (1991) scale (e.g. hyperkeratotic AKs),
- Subject with pigmented AK on the TAs,
- Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons;
- Subject with porphyria,
- Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs which, in the opinion of the investigator, might interfere with the interpretation of the clinical results,
- Subject with systemic diseases that, in the opinion of the investigator might interfere with the interpretation of the clinical results,
- History of hypersensitivity to nut products (e.g. peanut and almond oil) or soya,
- Subject with a known past history of skin cancer in the TAs
- Past history of skin melanoma
- The Subject has received, applied or taken the following treatments or Procedures within the specified time frame prior to the Baseline visit:
Topical treatment(s) on TAs:
5-Fluorouracil, diclofenac, imiquimod, retinoids, ingenol mebutat (Pep-005) : Duration 12 weeks
Surgical: elliptical excision, excision and reconstructive surgery, Mohs’ micrographic surgery, chemical peels/chemosurgery, cryosurgery, dermabrasion: Duration 12 weeks
PDT: Duration 12 weeks
Laser: Duration 12 weeks
Electrocoagulation: Duration 12 weeks
Radiotherapy and UV radiation therapy: Duration 12 weeks
Investigative therapies for Actinic Keratoses: Duration 12 weeks
Alpha-hydroxy acid, salicylic acid ointment, urea: Duration 2 weeks
Systemic treatment(s)
Systemic retinoids: Duration 12 weeks
Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs acting on immunophilins, interferon, opioids , TNF binding proteins, Mycophenolate, small biologics agents):Duration 12 weeks

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary efficacy objective:<br>To show the non-inferior efficacy of Metvix® Natural Day Light Photo Dynamic Therapy (NDL-PDT) versus Metvix® conventional Photo Dynamic Therapy (c-PDT) in Subjects with mild and moderate AKs at Week 12 in terms of percent reduction in lesions count.<br><br>Primary safety objective:<br>To compare the Subject’s self-assessment of pain of Metvix® NDL-PDT with that of Metvix® c-PDT. <br>;Secondary Objective: Not Applicable;Primary end point(s): Primary efficacy endpoint(s) <br>The primary efficacy endpoint is the lesion complete response rate, defined as the percentage of pre-existing and treated lesions at baseline that were assessed as clear at Week 12.<br>;Timepoint(s) of evaluation of this end point: At week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary efficacy endpoint(s)<br>- Lesion complete response rate for mild lesions only.<br>- Subject-side complete response rate defined as the percentage of subjects with all treated lesions clear in the corresponding TA, at Week 12.<br>- change in lesion severity<br>- number of new lesion<br><br>Primary Safety endpoint<br>- subject's self assessment of pain at baseline post-PDT procedures<br><br>Secondary Safety endpoint<br>- Incidence and severity of Adverse Events<br>- skin aspect of lesion in complete response <br><br>Other endpoint: weather and light asessment;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoint(s): at week 12<br><br>Safety primary endpoint: at Baseline post PDT-procedure<br><br>Secondary safety endpoint:<br>- adverse event: all along the study<br>- skin aspect at week 12

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