Topical NVN1000 for the Treatment of External Genital and Perianal Warts

Novan

Status and phase: Completed; Phase 2

Conditions: Perianal Warts; Genital Warts

Treatments: Drug: NVN1000 8% Gel; Drug: NVN1000 24%; Drug: Vehicle; Drug: NVN1000 16%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02462187

NI-WA201

Details and patient eligibility

About

A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts

Full description

This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.

Enrollment: 108 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area
• If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception
• If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study

Exclusion criteria

• Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system
• Pregnant, planning to become pregnant, or nursing
• History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin
• Recent history of other genital skin infections
• Active HSV and frequent HSV recurrences unless receiving suppression therapy
• Have hemoglobin < 10 G/dl or methemoglobin > 3%
• Known allergy to any component of the gel including excipients
• Previously participated in any study with NVN1000 or SB204

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 5 patient groups, including a placebo group

NVN1000 8% Gel twice daily

Experimental group

Description:

NVN1000 8% Gel twice daily

Treatment:

Drug: NVN1000 8% Gel

NVN1000 8% Gel once daily

Experimental group

Description:

NVN1000 8% Gel once daily

Treatment:

Drug: NVN1000 8% Gel

NVN1000 16% Once daily

Experimental group

Description:

NVN1000 16% Gel once daily

Treatment:

Drug: NVN1000 16%

Vehicle Gel

Placebo Comparator group

Description:

Vehicle Gel at frequency to match active

Treatment:

Drug: Vehicle

NVN1000 24% once daily

Experimental group

Description:

NVN1000 24% once daily

Treatment:

Drug: NVN1000 24%