Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma Diseases

• Status: Terminated
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in patients with fibrotic and atrophic cutaneous lesions in scleroderma diseases during the inactive stage of the disease (experiencing dystrophic outcomes of the disease with no inflammatory component at the time of enrolment).

The patients enrolled will be evaluated at study site at screening (V1), then after 3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration) (V2). After completion of the study treatment period, the patients will be followed for an additional period of 3 months without study medication, after which the patient will visit the site for the last visit (V3). 1 investigational site. 45 patients enrolled (included drop-outs).3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mastelli S.r.l
• Collaborator: Sintesi Research Srl

Criteria

Inclusion Criteria:

1. Male or female age > 18 years.

2. Patients diagnosed with localized scleroderma diseases during inactive stage with fibrotic and atrophic cutaneous lesions confirmed histologically.

3. Understanding the nature of the study and Signature of the written informed consent.

4. Negative pregnancy test at study entry for females of child bearing potential.

5. If the patient is a female of childbearing potential (less than 24 months since the last menstrual bleeding), she is using an acceptable and effective method of contraception during the study period.

Exclusion Criteria:

1. Patients under treatment with steroid therapy and/or systemic immunosuppressive therapy within 1 month prior to screening.

2. Patients with ongoing infectious processes at the level of target lesions.

3. Women who are pregnant or breast feeding.

4. Know allergy or hypersensitivity to the active principle of the investigational drug or to one of its excipients.

5. Patients with a condition or concurrent severe and/or uncontrolled medical disease which could compromise his/her participation, compliance with and/or completion of study procedures.