Recruitment

Recruitment Status
Completed

Inclusion Criteria

Body mass index (BMI) between 18 and 30kg/m2, inclusive
At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
...
Body mass index (BMI) between 18 and 30kg/m2, inclusive
At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
Fitzpatrick skin type I-II-III-IV

Exclusion Criteria

Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
For women, a positive pregnancy test and/or nursing at screening
Positive test results for Hepatitis B, Hepatitis C or HIV
...
Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
For women, a positive pregnancy test and/or nursing at screening
Positive test results for Hepatitis B, Hepatitis C or HIV
A positive test for drugs of abuse at screening
Have received cryotherapy in the treatment area within 60 days prior to enrollment
History of alcohol or illicit drug abuse
Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.

Summary

Conditions
Cutaneous Warts
Type
Interventional
Phase
Phase 1Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criteria

Body mass index (BMI) between 18 and 30kg/m2, inclusive
At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
...
Body mass index (BMI) between 18 and 30kg/m2, inclusive
At least 4 cutaneous warts on the hands, separated by at least 1cm of skin
Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
Fitzpatrick skin type I-II-III-IV

Exclusion Criteria

Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
For women, a positive pregnancy test and/or nursing at screening
Positive test results for Hepatitis B, Hepatitis C or HIV
...
Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
For women, a positive pregnancy test and/or nursing at screening
Positive test results for Hepatitis B, Hepatitis C or HIV
A positive test for drugs of abuse at screening
Have received cryotherapy in the treatment area within 60 days prior to enrollment
History of alcohol or illicit drug abuse
Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.

Tracking Information

NCT #
NCT02106260
Collaborators
Not Provided
Investigators
  • Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research
  • J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research