NCT04823845

Brief Summary

This study seeks to research the efficacy of Adapalene 0.1% gel as a cost effective and low risk treatment option for plantar warts of the foot. Patients that present/diagnosed in designated clinics with plantar warts will be offered the option of being treated with regular superficial debridements of the epidermis and twice a day application of adapalene gel 0.1% under occlusion. Patients will be followed until resolution.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2022

Shorter than P25 for early_phase_1

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 5, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

March 5, 2021

Last Update Submit

April 11, 2023

Conditions

Keywords

WartAdapalene

Outcome Measures

Primary Outcomes (1)

  • Time Until Plantar Wart Resolution

    days

    30-60 days

Study Arms (1)

Plantar Wart Treatment Using Adapalene Gel 0.1%

EXPERIMENTAL

patients treated for plantar warts with Adapalene 0.1% gel

Drug: Topical Adapalene Gel 0.1%

Interventions

applying Adapalene Gel 0.1% to plantar warts topically

Plantar Wart Treatment Using Adapalene Gel 0.1%

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients must be diagnosed with plantar warts

You may not qualify if:

  • pregnant women
  • previous wart treatment within the last 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Gupta R, Gupta S. Topical adapalene in the treatment of plantar warts; randomized comparative open trial in comparison with cryo-therapy. Indian J Dermatol. 2015 Jan-Feb;60(1):102. doi: 10.4103/0019-5154.147835.

    PMID: 25657417BACKGROUND
  • Gupta R. Plantar warts treated with topical adapalene. Indian J Dermatol. 2011 Sep-Oct;56(5):513-4. doi: 10.4103/0019-5154.87135.

    PMID: 22121266BACKGROUND
  • Vlahovic TC, Khan MT. The Human Papillomavirus and Its Role in Plantar Warts: A Comprehensive Review of Diagnosis and Management. Clin Podiatr Med Surg. 2016 Jul;33(3):337-53. doi: 10.1016/j.cpm.2016.02.003. Epub 2016 Mar 29.

    PMID: 27215155BACKGROUND

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
patient information will be kept secure and no individual identifiers will be used.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: apply study treatment to single group of patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

April 1, 2021

Study Start

May 1, 2022

Primary Completion

December 10, 2022

Study Completion

February 10, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

IPD will only be obtained/used by the researchers and no individual patient identifiers will be used.