Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis

Vidac Pharma

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: 10% VDA-1102; Drug: Placebo; Drug: 5% VDA-1102

Study type: Interventional

Funder types: Industry

Identifiers

NCT02844777

VDA-CP-03

Details and patient eligibility

About

This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled, multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult subjects.

Full description

Approximately 84 subjects who meet the study's enrollment criteria at the completion of the Screening Period will be randomized to receive 5% or 10% VDA-1102, or matched-placebo. During the Treatment Period, study drug will be applied once-daily for 28 days to a 25 square centimeter area of skin containing 4-8 actinic keratosis lesions on the face or scalp. Subjects will be followed for an additional 28 days (Observation Period) wherein no study drug will be applied.

The purpose of the study is to determine whether once-daily application of VDA-1102 ointment for 28 days is effective and well-tolerated in the treatment of actinic keratosis of the face and scalp.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a single 25 square centimeter area of skin on their scalp or face

Main Exclusion Criteria:

• Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the study, or (d) fertile and they or their fertile partner is unable or unwilling to use the required contraceptive methods
• Subject is immunosuppressed
• Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
• Subject has used systemic retinoid therapy within 6 months of Screening Visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Excipeint alone

Treatment:

Drug: Placebo

5% VDA-1102

Experimental group

Description:

Active study medication

Treatment:

Drug: 5% VDA-1102

10% VDA-1102

Experimental group

Description:

Active study medication

Treatment:

Drug: 10% VDA-1102