Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00859534
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects with a diagnosis of solar urticaria (confirmed by phototesting) of sufficient severity that they have requested treatment to alleviate symptoms.
* React to provocation with a light source
* Aged 18-70 years
* Fitzpatrick Skin Type I- IV
* Written informed consent prior to the performance of any study-specific procedure.
Exclusion Criteria:
* Allergy to CUV1647 or the polymer contained in the implant
* Any co-existent photodermatosis such as polymorphic light eruption (PLE), discoid lupus erythematosus (DLE) or erythropoietic porphyria (EPP).
* Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi.
* Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions.
* Diagnosed with HIV/AIDS or hepatitis.
* Any evidence of organ dysfunction or deviation from normal the clinical or laboratory determinations judged to be clinically significant by the Investigator.
* History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine (including diabetes, Cushing's syndrome, Addison's disease, Peutz-Jeagher syndrome), neurological (including seizures), haematological (especially anaemia of less than 10 g/100 mL) or systemic disease judged to be clinically significant by the Investigator.
* Acute history of drug or alcohol abuse (in the last 12 months).
* Major medical or psychiatric illness.
* Patient assessed as not suitable for the study in the opinion of the investigator (e.g. noncompliance history, allergic to local anaesthetics, faints when given injections or giving blood).
* Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device).
* Sexually active men with partners of child bearing potential not using barrier contraception during the trial and for a period of three months hereafter.
* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
* Any factors that may affect skin reflectance measurements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00859534
Study Brief:
Protocol Section:
NCT00859534