EUCTR2015-005100-28-IT
Active, not recruiting
Phase 1
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. - A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in p
MASTELLI SR0 sites45 target enrollmentJanuary 17, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Fibrotic and atrophic cutaneous lesions in localized scleroderma diseases.
- Sponsor
- MASTELLI SR
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
- •\* Methods of birth control which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, some intrauterine devices (IUDs), condom (for the partner), sexual abstinence or vasectomized partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 21
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\.Known 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.
Outcomes
Primary Outcomes
Not specified
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