NCT03388255

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

Terminated Phase 4 Last updated 16 September 2021

What this trial tests

Phase 4 trial testing Polydeoxyribonucleotides in Scleroderma Disease in 25 participants. Terminated before completion.

Timeline

8 November 2016

Primary endpoint
30 October 2019

31 October 2019

Quick facts

Lead sponsor	Mastelli S.r.l
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	8 November 2016
Primary completion	30 October 2019
Estimated completion	31 October 2019
Sites	1 location across Italy

Drugs / interventions tested

• Polydeoxyribonucleotides — full drug profile →

Conditions studied

• Scleroderma Disease — all drugs for Scleroderma Disease →

Sponsor

Mastelli S.r.l

Who can join

18 and older, any sex, with Scleroderma Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Morphea: The 2023 update.
   Papara C, De Luca DA, Bieber K, Vorobyev A, et al · · 2023 · cited 55× · PMID 36860340 · DOI 10.3389/fmed.2023.1108623
2. Upcoming treatments for morphea.
   Wenzel D, Haddadi NS, Afshari K, Richmond JM, et al · · 2021 · cited 20× · PMID 34272836 · DOI 10.1002/iid3.475
3. Polydeoxyribonucleotide for the improvement of a hypertrophic retracting scar-An interesting case report.
   Belmontesi M. · · 2020 · cited 10× · PMID 32892437 · DOI 10.1111/jocd.13710
4. Intramuscular Polydeoxyribonucleotides in Fibrotic and Atrophic Localized Scleroderma: An Explorative Prospective Cohort Study.
   Romagnuolo M, Moltrasio C, Marzano AV, Nazzaro G, et al · · 2023 · cited 2× · PMID 37189808 · DOI 10.3390/biomedicines11041190