Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

0.3 mL of CANDIN administered intralesionally in the largest common wart

0.5 mL of CANDIN administered intralesionally in the largest common wart

0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)

0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)

Candida albicans Skin Test Antigen for Cellular Hypersensitivity

CANDIN

0.9% Sodium Chloride Injection USP (non-preserved)

Placebo

Thomas Carpenter, DVM, PhD

This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20 weeks (10 doses administered every other week) or until a subject has complete resolution of all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for evidence of new or reoccurring warts and for safety evaluation.

Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)

Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study

Nielsen BioSciences, Inc.

Incidence of Treatment Emergent, Non-Injection Site Reactions

0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)

Placebo: 0.9% Sodium Chloride Injection USP (non-preserved)

Pooled Placebo

0.3 mL of CANDIN administered intralesionally in the largest common wart

CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Cohort 1

0.5 mL of CANDIN administered intralesionally in the largest common wart

CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Cohort 2

0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)

CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Cohort 3

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

CANDIN is currently marketed in the US and was used as indicated in this study as a recall antigen for detecting delayed-type hypersensitivity (DTH) following intradermal injection of 0.1 mL.

Response (size of induration) to CANDIN injection during screening

Body Weight

Body Mass Index

Left Hand

Right Hand

Left Arm

Right Arm

Left Leg

Right Leg

Left Foot (excluding sole)

Right Foot (excluding sole)

Location of Common Warts

Area of Primary Injected Wart

Age of Primary Injected Wart(s)

mITT- modified Intent to Treat population consisted of subjects that received at least one post baseline measurement of the primary wart(s).

David Burney, PhD, MBA

Modified Intent to Treat (mITT) - subjects that received at least one post baseline measurement of the primary wart(s)

Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit

mITT - Subjects that received at least one post baseline measurement of the primary wart(s)

Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit

Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit

mITT. Subjects that received at least one post baseline measurement of the primary wart(s). Cohort 3 values represent resolution of largest primary wart

Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)

Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)

mITT - Subjects that received at least on post baseline measurement of the primary wart(s)

Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts

Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)

Only mITT subjects with complete resolution of warts included in this endpoint

Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)

Tenderness

Pain

Pruritis/Itching

Edema/Swelling

Erythema/Redness

Peeling

Scarring

Safety Population- All randomized subjects who received at least one intralesional dose of study medication. Subjects experiencing multiple types of reactions were counted once for each type, but only once across all reactions.

Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%

Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.

mITT- Subjects that received at least one post baseline measurement of the primary wart(s)

Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart

Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.

mITT - subjects that received at least one post baseline measurement of the primary wart(s)

Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.

Naive

Cryotherapy

Surgery

Salicylic acid

Other

0.3 mL of CANDIN administered intralesionally in the largest common wart (Cohort 1) and multiple common warts (Cohort 3)

CANDIN: Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Cohort 1 and Cohort 3

mITT- Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)

Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History

Salicylic Acid

mITT - Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)

Spots Global Cancer Trial Database for candin

Every month we try and update this database with for candin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for candin

Every month we try and update this database with for candin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for candin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.