NCT02151630

Brief Summary

Plantar warts can be bothersome and painful requiring treatment. The investigators will compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts. Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70% or compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%) applying topically twice a day for 4 weeks. Patients will be visited every 2 weeks for one month after starting treatment and then every one month for up to 3 months. The number and size of warts will be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

May 28, 2014

Last Update Submit

May 29, 2014

Conditions

Plantar Wart

Keywords

wartverruca vulgaristopical therapypyruvic acidsalicylic acid

Outcome Measures

Primary Outcomes (2)

  • Wart number

    Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist. On each visit, warts will be inspected to determine the number of warts. Any wart totally non-detectable by inspection and touch will be considered as healed.

    From before to 3 months after

  • Wart size

    Patients will be visited every two weeks for one month and then every month for up to 3 months by a dermatologist. On each visit, warts will be inspected to determine the size of warts. The size of the warts will be calculated as the mean size of all the warts.

    From before to 3 months after

Study Arms (2)

Pyruvic acid

ACTIVE COMPARATOR

Patients will receive pyruvic acid solution 70% prepared by solving of pyruvic acid in water/ethanol solution. Patients will be advised to apply the solution twice daily for a period of four weeks. Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid.

Drug: Pyruvic acid

Salicylic acid

ACTIVE COMPARATOR

Patients will receive a combination of salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%. Patients will be advised to apply the solution twice daily for a period of four weeks. Application of petrolatum to the surrounding normal skin protects against the corrosive effect of the concentrated acid.

Drug: Salicylic Acid

Interventions

Pyruvic acidDRUG
Pyruvic acid
Salicylic AcidDRUG
Salicylic acid

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • aged 12 years and above
  • multiple warts (at least 2)

You may not qualify if:

  • mosaic warts
  • already under any treatment for warts
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Diseases and Leishmaniasis Research Center

Isfahan, Isfahan, Iran

RECRUITING

Related Publications (1)

  • Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.

    PMID: 21219294BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

Pyruvic AcidSalicylic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyruvatesKeto AcidsCarboxylic AcidsOrganic ChemicalsSalicylatesHydroxybenzoatesBenzoatesAcids, CarbocyclicHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Fatima Assaf, M.D.

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Assaf, M.D.

CONTACT

0098 913 0965384dr.assafsaid@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

IR(1)