Multi-centre, randomized, investigator-blind, intra-individual active and vehicle-controlled study, comparing Metvix® Natural Daylight Photodynamic Therapy versus Metvix® conventional Photodynamic Therapy in subjects with actinic keratosis
- Conditions
- Actinic (solar) Keratoses. Sunspot10040899
- Registration Number
- NL-OMON38765
- Lead Sponsor
- Galderma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
- 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.
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the lesion complete response rate, defined as<br /><br>the percentage of pre-existing and treated lesions at baseline that were<br /><br>assessed as clear at Week 12.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy endpoints<br /><br>- Lesion complete response rate for mild lesions only.<br /><br>- Subject-side complete response rate defined as the percentage of subjects<br /><br>with all treated lesions clear in the corresponding TA, at Week 12.<br /><br>- change in lesion severity<br /><br>- number of new lesion<br /><br><br /><br>Primary Safety endpoint<br /><br>- subject's self assessment of pain at baseline post-PDT procedures<br /><br><br /><br>Secondary Safety endpoint<br /><br>- Incidence and severity of Adverse Events<br /><br>- skin aspect of lesion in complete response<br /><br><br /><br>Other endpoint: weather and light asessment</p><br>