Study on the efficacy of laser treatment using a dye as an enhancer

Phase 1

• Conditions: venous and capillary vascular malformations; MedDRA version: 14.1Level: HLTClassification code 10047091Term: Vascular malformations and acquired anomaliesSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2009-009956-20-DE
• Lead Sponsor: Free State of Bavaria rep. by the Univ. of Regensburg, rep. by the Regensburg Univ. Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-17
• Study Completion: 2011-04-29
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified