A Study of A-101 Solution in Subjects With Common Warts.

NCT ID: NCT02669862

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-21
• Study Completion Date: 2016-09-16

Brief Summary

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.

Detailed Description

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.

Conditions

Common Warts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A-101 Solution 40

A-101 Solution 40% administered once per week

Group Type: EXPERIMENTAL

A-101 Solution 40

Intervention Type: DRUG

A-101 Solution 45

A-101 Solution 45% administered once per week

Group Type: EXPERIMENTAL

A-101 Solution 45

Intervention Type: DRUG

Vehicle Solution

Vehicle Solution administered once per week

Group Type: PLACEBO_COMPARATOR

Vehicle Solution

Intervention Type: DRUG

Interventions

A-101 Solution 40

Intervention Type: DRUG

A-101 Solution 45

Intervention Type: DRUG

Vehicle Solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject is at least 18 years of age

2. Subject has a clinical diagnosis of common warts

3. Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:

• Have a longest axis that is 3mm to 10mm
• Have a thickness ≤3mm
• Be a discrete lesion
• Be, when centered in the circular cutout of the provided template, the only common wart present
• Not be periungual, subungual, genital or anal
• Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatments or the study evaluations Not be in an area that may be occluded (by clothing, footwear or within a skin fold).

4. The Target Wart has a Physician Wart Assessment (PWA) ≥2

5. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study

6. Subject is non-pregnant and non-lactating

7. Subject is in good general health and free of any known disease state or physical condition which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations

8. Subject is willing and able to follow all study instructions and to attend all study visits

9. Subject is able to comprehend and willing to sign an Informed Consent Form.

Exclusion Criteria

1. Subject has clinically atypical warts on the trunk or extremities

2. Subject is immune compromised (due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)

3. Subject has a history of Human Immunodeficiency Virus (HIV) infection

4. Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to enrollment

5. Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:

• Immunotherapy (Candida antigen, mumps antigen, Trichophyton antigen);
• Anti-metabolite therapy (bleomycin, 5-fluorouracil)

6. Subject has used any of the following systemic therapies within the specified period prior to enrollment:

• Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab);
• Glucocortico-steroids (inhaled and intra-nasal steroids are permitted);

7. Subject has used any of the following topical therapies within the specified period prior to enrollment on, or in a proximity to the Target Wart, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:

• LASER (pulsed-dye laser), light (intense pulsed light, photo-dynamic therapy, other energy based therapy); Immuno-therapy ( imiquimod, squaric acid dibutyl ester, etc.); Anti-metabolite therapy (5-fluorouracil); Retinoids; Liquid nitrogen, electrodesiccation, curettage; Over-the-counter wart therapies

8. Subject has had any of the following within the specified period prior to enrollment on, or in a proximity to the target lesion, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:

• A cutaneous malignancy;
• A pre-malignancy (actinic keratosis)

9. Subject has a history of sensitivity to any of the ingredients in the study medications

10. Subject has any current skin disease (psoriasis, atopic dermatitis, eczema, sun damage, etc.), skin condition (sunburn, open wounds) or other disease or condition (uncontrolled diabetes) which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations

11. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aclaris Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart D Shanler, MD

Role: STUDY_DIRECTOR

Aclaris Therapeutics, Inc.

Locations

Aclaris Therapeutics, Inc.

Wayne, Pennsylvania, United States

Countries

United States

Other Identifiers

A-101-WART-201

Identifier Type: -

Identifier Source: org_study_id