A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of CUV1647 for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients - Phase II AK Study

Conditions: MedDRA version: 9.1Level: LLTClassification code 10000614Term: Actinic keratosis
Pre-cancerous skin lesions
MedDRA version: 9.1Level: LLTClassification code 10004146Term: Basal cell carcinoma
MedDRA version: 9.1Level: LLTClassification code 10041823Term: Squamous cell carcinoma

Registration Number: EUCTR2007-007015-89-SE

Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- Male and female organ transplant recipients with stable transplant function who received their transplant at least 2 years prior to study entry.
- Organ transplant patients who have had at least one biopsy-positive squamous cell carcinoma.
- Aged 18-75 years.
- Written informed consent prior to the performance of any study-specific procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any allergy to CUV1647 or the polymer contained in the implant.
- History of melanoma
- Current pigmentary disorders such as melasma.
- Diagnosed with HIV/AIDS, or Hepatitis B or C.
- Current history of drug or alcohol abuse (in the last 1 year).
- Clinically significant organ dysfunction, history of medical disorders or other factors (e.g. non-compliance history, allergic to local anaesthetics, faints when given injections or giving blood) which in the opinion of the investigator will interfere with the interpretation of the study outcome measures.
- Major medical or psychiatric illness.
- Pregnancy as confirmed by positive serum ß-HCG pregnancy test prior to baseline or lactating mothers.
- Females of child bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).
-Participation in a clinical trial of an investigational agent within 30 days prior to the screening visit.
- use of regular medications or any other factor that may affect skin pigmentation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine the effect of CUV1647 administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands during a 24 month test period.;Secondary Objective: - To determine and compare the proportion of patients in each group that develops one or more SCC during a 24 month test period.<br>- To examine the effect of ongoing sun exposure on lesion formation and progression in this patient group.<br>- To evaluate the safety and tolerability of multiple slow release subcutaneous implants of CUV1647.;Primary end point(s): Primary efficacy endpoint:<br>-Number of AK lesions will be systematically mapped, counted and photographed.<br><br>Primary safety endpoint:<br>- Incidence of any toxicities as judged from Adverse Events.

Secondary Outcome Measures