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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT03388255
• Date of registration: 21/12/2017
• Prospective Registration: No
• Primary sponsor: Mastelli S.r.l
• Public title: Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma Diseases
• Scientific title: 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
• Date of first enrolment: November 8, 2016
• Target sample size: 25
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03388255
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Simona Muratori, Dr
• Affiliation: IRCCS Ca' Granda Osp. Maggiore Policlinico

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Scleroderma Disease

Intervention(s)

Drug: Polydeoxyribonucleotides

Primary Outcome(s)

Localized Scleroderma Cutaneous Assessment Tool - LOSCAT [Time Frame: 6 months]

Secondary Outcome(s)

ultrasound profile [Time Frame: 6 months]

Dermatology Life Quality Index (DLQI) [Time Frame: 6 months]

histology improvement [Time Frame: 3 months]

tele-thermographic profile [Time Frame: 6 months]

Secondary ID(s)

PDRN-01-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sintesi Research Srl