A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in patients with cutaneous lesions in scleroderma diseases.

Phase 1

• Conditions: Fibrotic and atrophic cutaneous lesions in localized scleroderma diseases.; MedDRA version: 20.0Level: HLTClassification code 10039711Term: Scleroderma and associated disordersSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-005100-28-IT
• Lead Sponsor: MASTELLI SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-17
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified