DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

Plain-language guide to NCT02206477: phase 2, phase 3 randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent), 110 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02206477
Phase: phase 2, phase 3
Status: status unknown
Start: 2014-08
Completion (planned or actual): 2017-12
Participants: 110 (estimated)
Design: randomized, triple-blind, treatment
Conditions studied: Breast Capsular Contracture; Dimethyl Sulfoxide
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2, phase 3) is built around DMSO (dimethyl sulfoxide, non-peptide solvent).

Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery, with high incidence after radiotherapy.

The mechanism of the contraction is unclear, but is believed to be similar to the formation of hypertrophic scarring.

It had two arms (groups): DMSO treatment group (experimental) and the control group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

110 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: autologous reconstruction; single-stage alloplastic reconstruction; intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got DMSO (dimethyl sulfoxide, non-peptide solvent) and who got the comparison, which limits bias.

The DMSO (dimethyl sulfoxide, non-peptide solvent) group and the comparison group ran side by side rather than switching.

As a double-blind DMSO (dimethyl sulfoxide, non-peptide solvent) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-08 with completion listed for 2017-12.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example evidence of less inflamation and fibrosis in pathology examination of the capsule.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 110 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the DMSO (dimethyl sulfoxide, non-peptide solvent) compound page, all human trials.

Our Notes on the Compound

DMSO (dimethyl sulfoxide, non-peptide solvent): A solvent that carries substances through skin and into the blood, described as a free-radical scavenger; not a peptide.

DMSO (dimethyl sulfoxide, non-peptide solvent) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.