Trial Outcomes & Findings for Candin Safety & Efficacy Study for the Treatment of Warts (NCT NCT01757392)

NCT ID: NCT01757392

Last Updated: 2021-02-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
• Results posted on: 2021-02-04

Participant Flow

Participant milestones

Measure	Candin® 0.3 mL Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Overall Study STARTED	39
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Candin® 0.3 mL Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Overall Study Withdrawal by Subject	1
Overall Study Screen Fail	3

Baseline Characteristics

Candin Safety & Efficacy Study for the Treatment of Warts

Baseline characteristics by cohort

Measure	Candin® 0.3 mL n=35 Participants Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesion resolves or up to 6 injections.
Age, Continuous	39.9 years STANDARD_DEVIATION 11.76 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	34 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
Weight	87.32 Kg STANDARD_DEVIATION 22.508 • n=5 Participants
Height	173.52 cm STANDARD_DEVIATION 10.982 • n=5 Participants
Body Mass Index (BMI)	28.66 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants

PRIMARY outcome

Timeframe: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months

Outcome measures

Measure	Candin® 0.3 mL n=35 Participants Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Number of Participants With Complete Resolution of Primary Injected Wart	19 Participants

SECONDARY outcome

Timeframe: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months

Population: Subjects experiencing complete resolution of the primary injected wart

Outcome measures

Measure	Candin® 0.3 mL n=19 Participants Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits Four Injection visits	4 Participants
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits Five Injection visits	1 Participants
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits One Injection visit	5 Participants
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits Two Injection visits	4 Participants
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits Three Injection visits	3 Participants
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits Six Injection visits	2 Participants

POST_HOC outcome

Timeframe: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months

Outcome measures

Measure	Candin® 0.3 mL n=18 Participants Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits One injection visit	5 Participants
Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits Two injection visits	2 Participants
Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits Three Injection visits	5 Participants
Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits Four Injection visits	1 Participants
Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits Five Injection visits	0 Participants
Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits Six Injection visits	5 Participants

POST_HOC outcome

Timeframe: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months

Outcome measures

Measure	Candin® 0.3 mL n=12 Participants Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits One injection visit	0 Participants
Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits Two injection visits	0 Participants
Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits Three injection visits	2 Participants
Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits Four injection visits	4 Participants
Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits Five injection visits	3 Participants
Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits Six injection visits	3 Participants

POST_HOC outcome

Timeframe: 4 months after last injection

Number of participants with recurrence of primary wart seen at the final follow up visit

Outcome measures

Measure	Candin® 0.3 mL n=19 Participants Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Recurrence of Resolved Primary Wart at Follow up 2 Visit	4 Participants

Adverse Events

Candin® 0.3 mL

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Candin® 0.3 mL n=35 participants at risk Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml until lesion resolves or up to 6 injections.
Hepatobiliary disorders Cholecystitis	2.9% 1/35 • Number of events 1 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)

Other adverse events

Measure	Candin® 0.3 mL n=35 participants at risk Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml until lesion resolves or up to 6 injections.
General disorders Injection site erythema	91.4% 32/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
General disorders Injection site Pain	91.4% 32/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
General disorders Injection site swelling	88.6% 31/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
General disorders Injection site pruritus	57.1% 20/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Nervous system disorders Headache	31.4% 11/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
General disorders Fatigue	28.6% 10/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
General disorders Injection site exfoliation	25.7% 9/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
General disorders Influenza like illness	22.9% 8/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Gastrointestinal disorders Diarrhea	14.3% 5/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
General disorders Injection site vesicles	14.3% 5/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Gastrointestinal disorders Nausea	11.4% 4/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Respiratory, thoracic and mediastinal disorders Wheezing	11.4% 4/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Infections and infestations Sinusitis	8.6% 3/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Infections and infestations Upper respiratory tract infection	5.7% 2/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Investigations Alanine aminotranferase increased	5.7% 2/35 • All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)

Additional Information

David Burney

Nielsen Biosciences, Inc

Phone: 858-571-2726

Email: david@nielsenbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place