Status:
TERMINATED
Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma Diseases
Lead Sponsor:
Mastelli S.r.l
Collaborating Sponsors:
Sintesi Research Srl
Conditions:
Scleroderma Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 sc...
Detailed Description
This is a phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ® Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use i.m. in patients with fibrotic and...
Eligibility Criteria
Inclusion
- Male or female age \> 18 years.
- Patients diagnosed with localized scleroderma diseases during inactive stage with fibrotic and atrophic cutaneous lesions confirmed histologically.
- Understanding the nature of the study and Signature of the written informed consent.
- Negative pregnancy test at study entry for females of child bearing potential.
- 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
- Patients under treatment with steroid therapy and/or systemic immunosuppressive therapy within 1 month prior to screening.
- Patients with ongoing infectious processes at the level of target lesions.
- Women who are pregnant or breast feeding.
- Know allergy or hypersensitivity to the active principle of the investigational drug or to one of its excipients.
- 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.
Key Trial Info
Start Date :
November 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03388255
Start Date
November 8 2016
End Date
October 31 2019
Last Update
September 16 2021
Active Locations (1)
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1
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 21122