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Trial record 12 of 347 for:    scleroderma

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

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ClinicalTrials.gov Identifier: NCT03388255
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Sintesi Research Srl
Information provided by (Responsible Party):
Mastelli S.r.l

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 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).


Condition or disease Intervention/treatment Phase
Scleroderma Disease Drug: Polydeoxyribonucleotides Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 8, 2016
Estimated Primary Completion Date : March 8, 2018
Estimated Study Completion Date : September 8, 2018


Arm Intervention/treatment
Experimental: Polydeoxyribonucleotides

PLACENTEX: Polydeoxyribonucleotides 5.625 mg/3 ml for parenteral use i.m.

The study period consists of the following phases:

  • Treatment period: 3 months (daily i.m. treatment with PLACENTEX ® Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use, one vial per day for intra-muscular administration).
  • Follow up period: 3 months after end of active treatment, without study medication.
Drug: Polydeoxyribonucleotides

Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use i.m.

The study period consists of the following phases:

  • Treatment period: 3 months (daily i.m. treatment with PLACENTEX ® Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use, one vial per day for intra-muscular administration).
  • Follow up period: 3 months after end of active treatment, without study medication.
Other Name: PLACENTEX



Primary Outcome Measures :
  1. Localized Scleroderma Cutaneous Assessment Tool - LOSCAT [ Time Frame: 6 months ]
    The LoSCAT assesses 18 cutaneous anatomic sites, capturing both disease activity (mLoSSI) and damage (LoSDI) parameters. This score will take into consideration all the cutaneous lesions resulting from localized scleroderma diseases during the inactive stage of the disease.Scores for each site are based on the most severe score for each parameter. In order to minimize inter-subject variability, all skin changes are compared with the contralateral or ipsilateral skin area.


Secondary Outcome Measures :
  1. tele-thermographic profile [ Time Frame: 6 months ]
    Changes in the tele-thermographic profile of target cutaneous lesion following treatment with drug, according to Investigator's judgment

  2. ultrasound profile [ Time Frame: 6 months ]
    Changes in the ultrasound profile of target cutaneous lesion following treatment with drug, according to Investigator's judgment.

  3. histology improvement [ Time Frame: 3 months ]
    Measurement of histology improvement of target cutaneous lesion following treatment with drug through a validated score ranging from 0 (none) to 3 (high) with regard to the presence of epidermal, dermal, hypodermic and skin appendages atrophy as well as dermal and hypodermic sclerosis, according to Investigator's judgment.

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

    It is a simple 10-question validated questionnaire. The aim of the questionnaire is to measure how much patient's skin problem has affected patient's life. The scoring of each question is as follows:

    Very much scored 3 A lot scored 2 A little scored 1 Not at all scored 0 Not relevant scored 0 Question 7, 'prevented work or studying' scored 3 The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimumof 0. The higher the score, the more quality of life is impaired.

    HOW TO INTERPRET MEANING OF DLQI SCORES 0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388255


Contacts
Contact: Giulia Cattarini, Dr +3901845111 dirmed@mastelli.com

Locations
Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 21122
Contact: Simona Muratori, Dr    +390255035186      
Principal Investigator: Simona Muratori, Dr         
Sponsors and Collaborators
Mastelli S.r.l
Sintesi Research Srl
Investigators
Principal Investigator: Simona Muratori, Dr IRCCS Ca' Granda Osp. Maggiore Policlinico

Responsible Party: Mastelli S.r.l
ClinicalTrials.gov Identifier: NCT03388255     History of Changes
Other Study ID Numbers: PDRN-01-16
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mastelli S.r.l:
Polydeoxyribonucletide
Placentex
PDRN

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases