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

NCT00797706 | Unknown Phase 1

• 2 other identifiers: CS-201EudraCT No. 2007-002695-34
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

• To investigate safety and local tolerance of CHRONSEAL® cream containing 2 different concentrations of API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.

  From start of treatment to 12 weeks post treatment

Secondary Outcomes (1)

• To investigate the treatment effect on ulcer area reduction and changes of ulcer condition of CHRONSEAL® cream, containing 2 different concentrations API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.

  From start of treatment to 12 weeks post treatment

Study Arms (3)

Vehicle

PLACEBO COMPARATOR

Drug: CHRONSEAL

Low dose

EXPERIMENTAL

Drug: CHRONSEAL

High dose

EXPERIMENTAL

Drug: CHRONSEAL

Interventions

CHRONSEAL DRUG

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

High dose; Low dose; Vehicle

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian male or clinically sterile female subjects
• years or older.
• Ankle brachial index of at least 0.6.
• Written informed consent obtained.
• Subject legally competent and able to communicate effectively.
• Subject likely to co-operate.
• Uncomplicated venous ulcer as by clinical diagnosis.
• Full skin ulcer.
• Localisation above the foot and below the knee (wrist and malleoli included)
• Duration of at least 3 months.
• Area 3-20 cm2.

You may not qualify if:

• Visible signs of infection, black necrosis or discharge in the target ulcer.
• More than \~20% slough after debridement.
• Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol.
• Other known etiology of the target ulcer.
• Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs.
• 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.
• Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives
• 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
• Diabetes Mellitus requiring pharmaceutical treatment.
• Co-morbidity with a life expectancy less than 6 months.
• Co-morbidity expected to lower compliance.
• Diagnosed kidney disease

Sponsors & Collaborators

• Kringle Pharma Europe AB: lead
• Kringle Pharma, Inc.: collaborator

Study Sites (16)

Medi3 Innlandet AS, Department Elverum

Elverum, 2402, Norway

Location

Hudavdelingen Helse

Førde, 6807, Norway

Location

Medi 3 Innlandet AS, Department Hamar

Hamar, 2317, Norway

Location

Colosseumklinikken

Oslo, 0369, Norway

Location

Vårdcentralen Alvesta

Alvesta, 342 30, Sweden

Location

Danderyds Sjukhus AB

Danderyd, SE-182 88, Sweden

Location

Carema Vårdcentral Gubbängen

Enskede, SE-122 45, Sweden

Location

Department of Dermatology and Infectious diseases

Halmstad, SE-301 85, Sweden

Location

Husläkarna i Kungsbacka

Kungsbacka, SE-434 30, Sweden

Location

Department of Dermatology, Lund University hospital

Lund, SE-221 85, Sweden

Location

Department of Dermatology, University Hospital MAS

Malmo, SE-205 02, Sweden

Location

Gamla Stans Vårdcentral

Stockholm, SE-111 29, Sweden

Location

Taptogatans Husläkare

Stockholm, SE-115 26, Sweden

Location

Department of Dermatology, Norrlands University hospital

Umeå, SE-901 85, Sweden

Location

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

Uppsala, SE-751 05, Sweden

Location

Neptunuskliniken

Varberg, SE-432 44, Sweden

Location

Study Officials

• Hans Olav Høivik, MD

  Medi 3 Innlandet AS, avd Hamar

  PRINCIPAL INVESTIGATOR

• Karin Andersson, MD

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

  PRINCIPAL INVESTIGATOR

• Jan Apelqvist, Assoc. Prof., PhD, MD

  Department of Endocrinology, University Hospital Malmö,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 5, 2010

Record last verified: 2010-02

Locations

SE (12); NO (4)