Safety Study of A-101 Topical Solution for the Treatment of Common Warts



Status:Enrolling by invitation
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:1 - Any
Updated:3/22/2019
Start Date:February 7, 2019
End Date:January 15, 2020

Use our guide to learn which trials are right for you!

A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts

A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts

Inclusion Criteria:

- Subject or legal guardian is able to comprehend and is willing to sign an informed
consent/assent for participation in this study.

- Subject must have completed study participation in either A-101-WART-301 or
A-101-WART-302.

- Male or female ≥ 1 years old.

- Subject has a clinical diagnosis of common warts (verruca vulgaris).

- Identified warts must have a longest axis of ≤8 mm

Exclusion Criteria:

- Subject has clinically atypical warts.

- Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic
immunodeficiency, transplant status, etc.).

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

- Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit
1.

- Subject has used any of the following intralesional therapies within the specified
period prior to Visit 2:

1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8
weeks

2. Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks

- Subject has used any of the following systemic therapies within the specified period
prior to Visit 2:

1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept,
infliximab); 16 weeks

2. Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days

- Subject has used any of the following topical therapies within the specified period
prior to Visit 2 on or in the proximity to any of the common warts identified for
treatment that in the investigator's opinion interferes with the study medication
treatment or the study assessments:

1. LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL],
photodynamic therapy [PDT]); 180 days

2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.) 12
weeks

3. Liquid nitrogen, electrodesiccation, curettage; 60 days

4. Hydrogen peroxide; 90 days

5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks

6. Retinoids; 90 days

7. Over-the-counter (OTC) wart therapies and cantharidin; 28 days

- Subject currently has or has had any of the following within the specified period
prior to Visit 1 on or in a proximity to any of the common warts identified for
treatment that, in the investigator's opinion, interferes with the study medication
treatment or the study assessments:

1. Cutaneous malignancy; 180 days

2. Sunburn; currently

3. Pre-malignancy (e.g., actinic keratosis); currently

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

- Subject has any current skin or systemic disease (e.g., psoriasis, atopic dermatitis,
eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that,
in the opinion of the investigator, might put the subject at undue risk by study
participation or interfere with the study conduct or evaluations.

- Participation in another therapeutic investigational drug/device trial (other than the
Aclaris 301 or 302 study) in which administration of an investigational treatment
occurred within 30 days prior to Visit 1.

- Subject has an active malignancy.
We found this trial at
40
sites
Fort Washington, Pennsylvania 19034
Phone: 484-983-0045
?
mi
from
Fort Washington, PA
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Arlington, Texas 76011
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Austin, Texas 78759
?
mi
from
Austin, TX
Click here to add this to my saved trials
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Broomall, Pennsylvania 19008
?
mi
from
Broomall, PA
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
College Station, Texas 77845
?
mi
from
College Station, TX
Click here to add this to my saved trials
Denver, Colorado 80210
?
mi
from
Denver, CO
Click here to add this to my saved trials
Encinitas, California 92024
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
Fort Smith, Arkansas 72916
?
mi
from
Fort Smith, AR
Click here to add this to my saved trials
Fountain Inn, South Carolina 29644
?
mi
from
Fountain Inn, SC
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Fridley, Minnesota 55432
?
mi
from
Fridley, MN
Click here to add this to my saved trials
Glendale, Arizona 85308
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Knoxville, Tennessee 37922
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89148
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Louisville, Kentucky 40241
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lynchburg, Virginia 24501
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Miami, Florida 33137
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Nashville, Tennessee 37215
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Albany, Indiana 47150
?
mi
from
New Albany, IN
Click here to add this to my saved trials
Newnan, Georgia 30263
?
mi
from
Newnan, GA
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Omaha, Nebraska 68144
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Pflugerville, Texas 78660
?
mi
from
Pflugerville, TX
Click here to add this to my saved trials
Raleigh, North Carolina 27612
Phone: 484-983-0045
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, New York 14623
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Saint Joseph, Missouri 64506
?
mi
from
Saint Joseph, MO
Click here to add this to my saved trials
San Antonio, Texas 78213
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Upper Saint Clair, Pennsylvania 15241
Phone: 484-983-0045
?
mi
from
Upper Saint Clair, PA
Click here to add this to my saved trials
Verona, New Jersey 07044
?
mi
from
Verona, NJ
Click here to add this to my saved trials