venous and capillary vascular malformations MedDRA version: 14.1 Level: HLT Classification code 10047091 Term: Vascular malformations and acquired anomalies System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: ICG Pulsion(R)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: INDOCYANINE GREEN
CAS Number: 3599324
Other descriptive name: INDOCYANINE GREEN
Concentration uni
Sponsors
Free State of Bavaria rep. by the Univ. of Regensburg, rep. by the Regensburg Univ. Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent signed before or at Screening Visit by the patient (only adults). - Caucasian patients of both sexes. - Diagnosis of cutaneous venous and capillary vascular malformations at all sites of the skin except the hairy scalp. - Distance between study lesion borders is = 0.5 cm. - Skin sun sensitivity type I to IV according to Fitzpatrick. 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 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Pre-treatment of cutaneous venous and capillary vascular malformations eligible for study procedures during the 12 weeks preceding study treatment (e.g. cryotherapy, radiotherapy, laser treatment). - Treatment with systemic retinoids during the 3 months preceding study therapy. - Female patients with a positive pregnancy test. - Breast-feeding female patients. - Patients with clinically relevant suppression of the immune system. - Patients with non-controllable thyroid malfunction, for which administration of iodine is contraindicated. - Patients with an allergy against iodine. - Patients with severe liver malfunction. - Skin diseases that might interfere with response evaluation of study treatment. - Skin sun sensitivity type V or VI according to Fitzpatrick. - Proven sensitivity or adverse reactions to one or more of the ingredients of ICG. - Dementia or psychic conditions that might interfere with the ability to understand the study and thus give a written informed consent. - Planned extensive UV-exposure (UV-phototherapy, vacation, tanning studio) in the first 2 months after treatment. - Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion. - Suspected lack of compliance. - Uncooperative patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this pilot study is to evaluate the feasibility of a future main study, which will evaluate the efficacy of ICG-mediated laser for the treatment of cutaneous venous and capillary vascular malformations;Secondary Objective: Comparison of safety of and tolerability to study treatments. Cosmetic outcome 12 weeks after study treatments. Evaluation of parameters for a main trial. Possibility to recruit patients. Randomization and blinding. Calculation of patient number. Practicability and identification of problems of the design of the main study. ;Primary end point(s): clinical improvement 3 months following ICG-augmented laser therapy;Timepoint(s) of evaluation of this end point: 3 months following treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): efficacy, side effects, patient satisfaction;Timepoint(s) of evaluation of this end point: 3 months after treatment | — |
Countries
Germany
Contacts
Public ContactPhilipp Babilas, MD
University Hospital Regensburg
Outcome results
None listed