Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers (SSVS)

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ClinicalTrials.gov Identifier: NCT00832091

Recruitment Status : Completed

First Posted : January 29, 2009

Results First Posted : March 24, 2010

Last Update Posted : March 30, 2010

Sponsor:

Collaborator:

sigma-tau i.f.r. S.p.A.

Information provided by:

RegeneRx Biopharmaceuticals, Inc.

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

Condition or disease	Intervention/treatment	Phase
Venous Stasis Ulcers	Drug: Thymosin Beta 4 Drug: Placebo	Phase 2

Detailed Description:

The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Venous Stasis Ulcers
Study Start Date :	July 2006
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days	Drug: Thymosin Beta 4 There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days Other Names: Tβ4 RGN-137 (topical gel)
Placebo Comparator: 2 There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days	Drug: Placebo There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

Arm

Intervention/treatment

Active Comparator: 1

There are 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were 3 concentrations used for topical administration to the active drug groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days

Drug: Thymosin Beta 4

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days

Other Names:

Tβ4
RGN-137 (topical gel)

Placebo Comparator: 2

There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days

Drug: Placebo

Outcome Measures

Primary Outcome Measures :

Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days [ Time Frame: Up to 84 days ]
All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE

Secondary Outcome Measures :

Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers [ Time Frame: Up to 84 days ]
Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed Consent Form signed by the patient
Male or female, between 18 and 79 years of age
At least one venous leg ulceration stable for at least 6 weeks before enrollment
Surface area between 3 and 30 cm2

Exclusion Criteria:

Have clinical evidence of active infection on the index ulcer
Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment
History of adverse reaction to any ingredients of the study medication
Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers
Current or former malignancy
Arterial disorder resulting in ulcerated ulcers
Diabetes mellitus
Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed at screening for female patients of childbearing potential

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832091

Locations

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Italy
Chirurgia Vascolare
Bologna, Italy
Università degli Studi di Napoli - Federico II
Naples, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Unità Operativa di Angiologia Azienda Ospedaliera di Padova
Padova, Italy
Istituto Dermopatico dell'Immacolata (IDI)
Rome, Italy
Poland
Klinika Chirurgii Naczyń i Angiologii
Lublin, Poland
Klinika Chirurgii Ogólnej i Naczyniowej,
Szczecin, Poland
Oddział Angiologiczny
Wrocław, Poland

Sponsors and Collaborators

RegeneRx Biopharmaceuticals, Inc.

sigma-tau i.f.r. S.p.A.

Investigators

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Principal Investigator:	Giorgio Guarnera, MD	Istituto Dermopatico Dell'Immacolata, Rome , Italy

More Information

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Responsible Party:	Dr Giorgio Guarnera, Istituto Dermopatico dell'Immacolata (IDI), Rome, ITaly
ClinicalTrials.gov Identifier:	NCT00832091
Other Study ID Numbers:	SSVS
First Posted:	January 29, 2009 Key Record Dates
Results First Posted:	March 24, 2010
Last Update Posted:	March 30, 2010
Last Verified:	March 2010

Keywords provided by RegeneRx Biopharmaceuticals, Inc.:


Venous Stasis Ulcers venous insufficiency leg ulcers Thymosin Beta 4 Laminin-5

Additional relevant MeSH terms:

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Varicose Ulcer Ulcer Pathologic Processes Varicose Veins Vascular Diseases	Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases

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