Trial Title:
Candin for the Treatment of Common Warts
NCT ID:
NCT05889845
Condition:
Common Warts (Verruca Vulgaris)
Conditions: Official terms:
Warts
Conditions: Keywords:
Common wart
Intralesional injection
Candida albicans
Immunotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, Double-Blind, Placebo-Controlled Study
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Unblinded site staff will prepare syringes of study drug for administration by blinded
study staff
Intervention:
Intervention type:
Drug
Intervention name:
Candin, Intradermal Solution
Description:
Injection at the base of the selected wart
Arm group label:
Candin treatment
Intervention type:
Drug
Intervention name:
Placebo
Description:
Injection at the base of the selected wart
Arm group label:
Placebo
Summary:
The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age
and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following
treatment with Candin or placebo. The main questions it aims to answer are:
- does treatment with Candin result in better clearance of warts than placebo
- how many injections are required to result in wart clearance Participants will
- have one wart selected for injection every two weeks until clearance
- return 12 weeks after wart clearance for assessment of durability of response
Detailed description:
This study involves a comparison of an equal volume injection of Candin with an injection
of placebo (unpreserved normal saline solution) in common warts. Subjects will be
randomized 2:1 to receive Candin or placebo. During the Treatment Period, 1 dose (0.5 mL)
of investigational product (IP) will be injected every 2 weeks into a single treatment
wart until either clinical clearance of the treatment wart is achieved or a total of 10
injections have been administered.
Subjects achieving clinical clearance of the treatment wart will receive a final
injection at the site of the cleared wart and then immediately enter the Observational
Period for 12 weeks. Complete resolution is achieved when a subject demonstrates clinical
clearance for 12 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- At least 3, but not more than 20 common warts (Verruca vulgaris)
- Willing to agree to use adequate contraception methods during the study
Exclusion Criteria:
- Systemic or localized diseases, conditions, or medications that could interfere with
the assessment of safety or efficacy or that compromise immune function
- Candin delayed type hypersensitivity reaction test wheal sized < 5 mm or > 25 mm at
the Baseline Visit
- History of keloid formation
- Prior treatment of common warts with liquid nitrogen, carbon dioxide,
electrodesiccation, laser, surgery, salicylic acid, etc., that, in the
Investigator's opinion, does not exhibit complete healing from the treatment
- Treatment with immunotherapy (e.g., diphenylcyclopropenone [DPCP],
dinitrochlorobenzene [DNCB], or other), imiquimod, 5-fluorouracil, bleomycin, or
podophyllin within 12 weeks of the Baseline Visit or during the study
- Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or
during the study
- Systemic treatment with an immunosuppressive drug during the study or in the 6
months or 5 half lives prior to the Baseline Visit or during the study (e.g.,
azathioprine, 6 mercaptopurine, methotrexate, infliximab, adalimumab, etanercept,
systemic steroids [topical or inhaled steroids are acceptable]).
- Use of cantharidin or an investigational agent or device within the 30 days prior to
the Baseline Visit or during the study
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cahaba Dermatology
Address:
City:
Birmingham
Zip:
35244
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Perry
Phone:
205-778-1564
Email:
jperry@cahabaderm.com
Facility:
Name:
Arkansas Pediatric Clinic
Address:
City:
Bryant
Zip:
72022
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tim Dugan
Phone:
501-655-6138
Email:
tdugan@burkepharmaceutical.com
Facility:
Name:
Johnson Dermatology
Address:
City:
Fort Smith
Zip:
72916
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sandra Johnson, MD
Phone:
479-649-3376
Email:
drsandy@johnsondermatology.com
Facility:
Name:
Dermatology Clinic of Arkansas
Address:
City:
Hot Springs
Zip:
71913
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tim Dugan
Phone:
501-620-4449
Email:
tdugan@burkepharmaceutical.com
Facility:
Name:
Velocity Clinical La Mesa
Address:
City:
La Mesa
Zip:
91942
Country:
United States
Status:
Recruiting
Contact:
Last name:
Valerie Horne
Phone:
619-567-1550
Email:
vhorne@velocityclinical.com
Facility:
Name:
Long Beach Research
Address:
City:
Long Beach
Zip:
90805
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yelena Quintanilla
Phone:
562-471-3773
Email:
yquintanilla@longbeachresearch.com
Facility:
Name:
Integrative Skin Research
Address:
City:
Sacramento
Zip:
95815
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sydney Fong
Phone:
916-524-1216
Email:
sydney@integrativeskinresearch.com
Facility:
Name:
Velocity Clinical Englewood
Address:
City:
Englewood
Zip:
80110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Theresa O'Lonergan
Phone:
303-293-3733
Email:
tolonergan@velocityclinical.com
Facility:
Name:
Kaminska Dermatology
Address:
City:
Chicago
Zip:
60657
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ghadeer Samhan
Phone:
737-267-2111
Email:
kdermofficemanager@gmail.com
Facility:
Name:
Integrated Dermatology of Newton-Brighton
Address:
City:
Brighton
Zip:
02135
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stella Schandorf
Phone:
617-789-5300
Email:
sschandorf@metrobostoncp.com
Facility:
Name:
Hamzavi Dermatology
Address:
City:
Fort Gratiot
Zip:
48059
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Campbell
Phone:
810-455-1612
Email:
lcampbell@hamzavi.com
Facility:
Name:
Schlessinger MD
Address:
City:
Omaha
Zip:
68144
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kayleigh Koziol
Phone:
402-697-6599
Email:
kayleigh@lovelyskin.com
Facility:
Name:
Advocare Berlin Medical Associates
Address:
City:
Berlin
Zip:
08009
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeanette Caruso
Phone:
916-802-4097
Email:
j.caruso@cenexel.com
Facility:
Name:
Bryn Mawr Health Center
Address:
City:
Newtown Square
Zip:
19073
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Golding
Phone:
610-544-1715
Email:
michelle.golding@kglssc.com
Facility:
Name:
Velocity Clinical Spartanburg
Address:
City:
Spartanburg
Zip:
29303
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allison Kelly
Phone:
864-515-0092
Email:
akelly@velocityclinical.com
Facility:
Name:
DermResearch
Address:
City:
Austin
Zip:
78759
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karina Garcia
Phone:
512-349-9889
Email:
karina@vialtrials.com
Contact backup:
Last name:
Candice Nkwo
Facility:
Name:
Austin Institute for Clinical Research
Address:
City:
Pflugerville
Zip:
78660
Country:
United States
Status:
Recruiting
Contact:
Last name:
Celeste Katona
Phone:
512-279-2545
Email:
ckatona@atxresearch.com
Facility:
Name:
Velocity Clinical Hampton
Address:
City:
Hampton
Zip:
23666
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kenji Mizoguchi
Phone:
757-520-5111
Email:
kmizoguchi@velocityclinical.com
Start date:
March 5, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Nielsen BioSciences, Inc.
Agency class:
Industry
Source:
Nielsen BioSciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889845
