NCT03129373

Brief Summary

The present study was set-up to evaluate clinical efficacy of Pixie® cryogenic pen versus two comparator cryogenic products (Wartner® and Wortie®) for the treatment of common and plantar warts.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

April 3, 2017

Last Update Submit

September 18, 2017

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

  • Comparison of the percentage of subjects with clinical wart remission after 1 treatment in the Pixie® group versus comparators groups (Wartner® and Wortie®), as observed during a clinical evaluation of the treated wart by the dermatologist.

    After 1 treatment (approximately 15 days after the first treatment)

Secondary Outcomes (6)

  • Comparison of the number of treatments needed for clinical remission of warts with the three products.

    1 treatment (day 0), 2 treatments (day 15), 3 treatments (day 29)

  • Surface area measurements of frostbite area to evaluate the efficacy of the freezing process, during the three applications if applicable.

    1 treatment (day 0), 2 treatments (day 15), 3 treatments (day 29)

  • Illustration of the visual aspects of the wart remission with macrophotographs.

    Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)

  • Evaluation of the skin conditions at study end, assessed by the investigator by clinical evaluation.

    Before treatment (day 0 before treatment), after 1 treatment (day 15), after 2 treatments (day 29), after 3 treatments (day 45)

  • Recording of adverse events.

    On days 0, 3, 15, 29 and 45

  • +1 more secondary outcomes

Study Arms (3)

Pixie group

EXPERIMENTAL

Cryogenic treatment of wart (liquified nitrous oxide) * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet.

Device: Cryogenic treatment of warts

Wartner group

ACTIVE COMPARATOR

Cryogenic treatment of wart (dimethylether propane-based): * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet.

Device: Cryogenic treatment of warts

Wortie group

ACTIVE COMPARATOR

Cryogenic treatment of wart (dimethylether-based product): * Maximum 3 application by the technician in charge of the study. * Apply between 15 to 20 sec on hand and 40 sec on feet.

Device: Cryogenic treatment of warts

Interventions

Cryogenic treatment of wartsDEVICE

Treatment of common and plantar wart by cryotherapy treatment.

Pixie groupWartner groupWortie group

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subject.
  • Sex: male or female.
  • Age: more than 4 years old.
  • Subject presenting at least 1 new common wart on hand or on feet or plantar wart (wart present since less than 6 months).
  • Subject, including minors aged more than 14 years, having given freely and expressly his/her informed consent.
  • Minor whose legal guardians have given their free and express informed consent.
  • Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigator's appreciation.
  • Subject able to comply with protocol requirements, as defined in the protocol.
  • Subject or child's legal guardians being affiliated to a health social security system.
  • Female subjects of childbearing potential should use a medically accepted contraceptive regimen (at the Investigator's discretion) since at least 12 weeks before the beginning of the study, during all the study.

You may not qualify if:

  • Pregnant, parturient or nursing woman or planning a pregnancy during the study.
  • Subject who had been deprived of their freedom by administrative or legal decision.
  • Subject in a social or sanitary establishment.
  • Major subject who is under guardianship or who is not able to express his consent.
  • Subject suspected to be non-compliant according to the Investigator's judgment.
  • Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
  • Subject with a cutaneous disease other than common and plantar warts, on the studied zone.
  • Subject with a known allergy to one of the component of the products or to the comparator.
  • Subject who has diabetes.
  • Subject having problems with blood circulation, or having a blood clotting condition.
  • Subject with immune deficiency or autoimmune disease.
  • Subject presenting more than 10 warts on the body.
  • Subject presenting bleeding warts.
  • Subject presenting birthmarks, moles, warts with hairs growing from them, or any other spots.
  • Subject having a sensitive skin, inflamed, infected, irritated, red, damaged, cut, grazed, diseased or itchy on the treated zone.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Walczuk I, Eertmans F, Rossel B, Cegielska A, Stockfleth E, Antunes A, Adriaens E. Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study. Dermatol Ther (Heidelb). 2018 Jun;8(2):203-216. doi: 10.1007/s13555-017-0210-5. Epub 2017 Dec 6.

    PMID: 29214505DERIVED

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 26, 2017

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 19, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share