Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers

NCT ID: NCT00797706

Last Updated: 2010-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-03-31

Brief Summary

The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.

Conditions

Chronic Venous Leg Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vehicle

Group Type: PLACEBO_COMPARATOR

CHRONSEAL

Intervention Type: DRUG

Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

Low dose

Group Type: EXPERIMENTAL

CHRONSEAL

Intervention Type: DRUG

Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

High dose

Group Type: EXPERIMENTAL

CHRONSEAL

Intervention Type: DRUG

Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

Interventions

CHRONSEAL

Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Caucasian male or clinically sterile female subjects

2. 40 years or older.

3. Ankle brachial index of at least 0.6.

4. Written informed consent obtained.

5. Subject legally competent and able to communicate effectively.

6. Subject likely to co-operate.

7. Uncomplicated venous ulcer as by clinical diagnosis.

8. Full skin ulcer.

9. Localisation above the foot and below the knee (wrist and malleoli included)

10. Duration of at least 3 months.

11. Area 3-20 cm2.

1. Subject likely to co-operate.

2. Ulcer area reduction less than 50% during run-in period.

3. Ulcer area 3-20 cm2.

Exclusion Criteria

1. Visible signs of infection, black necrosis or discharge in the target ulcer.

2. More than ~20% slough after debridement.

3. Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol.

4. Other known etiology of the target ulcer.

5. Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs.

6. Concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer.

7. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives

8. Concomitant topical treatment within 14 days prior to start of study medication with any of the following:

• NSAIDs, aspirin
• Growth factors, or other biologically active agents
• Products containing chlorhexidine, potassium permanganate, iodine or silver

9. Diabetes Mellitus requiring pharmaceutical treatment.

10. Co-morbidity with a life expectancy less than 6 months.

11. Co-morbidity expected to lower compliance.

12. Diagnosed kidney disease

13. Individuals sensitive to any of the study medication components.

14. Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication.

15. Known abuse of alcohol, drugs or pharmaceuticals.

16. Diagnosis of squamous epithelia carcinoma

17. Diagnoses of a serious psychiatric illness which may influence study participation.

1.& 2. = Run-in period criteria 1. & 2.

3. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.

4.-10. = Run-in period criteria 6., 7., 8., 11., 12., 13., & 14

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kringle Pharma, Inc.

INDUSTRY

Sponsor Role: collaborator

Kringle Pharma Europe AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Kringle Pharma Europe AB

Principal Investigators

Hans Olav Høivik, MD

Role: PRINCIPAL_INVESTIGATOR

Medi 3 Innlandet AS, avd Hamar

Karin Andersson, MD

Role: PRINCIPAL_INVESTIGATOR

Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden

Jan Apelqvist, Assoc. Prof., PhD, MD

Role: STUDY_CHAIR

Department of Endocrinology, University Hospital Malmö,

Locations

Medi3 Innlandet AS, Department Elverum

Elverum, , Norway

Hudavdelingen Helse

Førde, , Norway

Medi 3 Innlandet AS, Department Hamar

Hamar, , Norway

Colosseumklinikken

Oslo, , Norway

Vårdcentralen Alvesta

Alvesta, , Sweden

Danderyds Sjukhus AB

Danderyd, , Sweden

Carema Vårdcentral Gubbängen

Enskede, , Sweden

Department of Dermatology and Infectious diseases

Halmstad, , Sweden

Husläkarna i Kungsbacka

Kungsbacka, , Sweden

Department of Dermatology, Lund University hospital

Lund, , Sweden

Department of Dermatology, University Hospital MAS

Malmo, , Sweden

Gamla Stans Vårdcentral

Stockholm, , Sweden

Taptogatans Husläkare

Stockholm, , Sweden

Department of Dermatology, Norrlands University hospital

Umeå, , Sweden

Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital

Uppsala, , Sweden

Neptunuskliniken

Varberg, , Sweden

Countries

Norway; Sweden

Other Identifiers

EudraCT No. 2007-002695-34

Identifier Type: -

Identifier Source: secondary_id

CS-201

Identifier Type: -

Identifier Source: org_study_id