A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts

• Sponsor: Aclaris Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03278028
• Collaborator: (none)
• Enrollment: 159
• Locations: 16
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site: 9.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

Condition or Disease	Intervention/Treatment	Phase
Common Wart	Drug: A-101 Topical Solution; Drug: A-101 Vehicle Solution	Phase 2

Detailed Description

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.

Study Design

• Study Type: Interventional
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts
• Actual Study Start Date: Jul 13, 2017
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active A-101 Topical Solutions	Drug: A-101 Topical Solution; A-101 Topical Solution
Placebo Comparator: Vehicle Vehicle	Drug: A-101 Vehicle Solution; A-101 Vehicle Solution

Outcome Measures

Primary Outcome Measures

1. Physician's Wart Assessment [Day 57]

   Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length) A visible wart ≥ 6 mm in maximal diameter (or length)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.

• Male or female ≥ 8 years old.

• Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.

• Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.

• Subject is non-pregnant and non-lactating.

• Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.

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

Exclusion Criteria:

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

• 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 1 year prior to Visit 1

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

• Subject has any current skin 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 trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aclaris Investigational Site	Glendale	Arizona	United States	85308
2	Aclaris Investigational Site	Fort Smith	Arkansas	United States	72916
3	Aclaris Investigational Site	Encinitas	California	United States	92024
4	Aclaris Investigational Site	Los Angeles	California	United States	90045
5	Aclaris Investigational Site	Denver	Colorado	United States	80210
6	Aclaris Investigational Site	Omaha	Nebraska	United States	68144
7	Aclaris Investigational Site	Albuquerque	New Mexico	United States	87106
8	Aclaris Investigational Site	Rochester	New York	United States	14623
9	Aclaris Investigational Site	High Point	South Carolina	United States	27262
10	Aclaris Investigational Site	Knoxville	Tennessee	United States	37922
11	Aclaris Investigational Site	Nashville	Tennessee	United States	37215
12	Aclaris Investigational Site	College Station	Texas	United States	77845
13	Aclaris Investigational Site	Houston	Texas	United States	77004
14	Aclaris Investigational Site	Salt Lake City	Utah	United States	84117
15	Aclaris Investigational Site	Lynchburg	Virginia	United States	24501
16	Aclaris Investigational Site	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Aclaris Therapeutics, Inc.

Investigators

• Study Director: Stuart D Shanler, MD, Aclaris Therapeutics

Study Documents (Full-Text)

• Study Protocol - Nov 20, 2017
• Statistical Analysis Plan - Dec 1, 2017

More Information

Publications

None provided.

• Responsible Party: Aclaris Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03278028
• Other Study ID Numbers: A-101-WART-203
• First Posted: Sep 11, 2017
• Last Update Posted: Apr 9, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Warts; Pharmaceutical Solutions

Study Results

Participant Flow

Arm/Group Title	Active	Vehicle
Arm/Group Description	A-101 Topical Solutions A-101 Topical Solution: A-101 Topical Solution	Vehicle A-101 Vehicle Solution: A-101 Vehicle Solution
Period Title: Overall Study
STARTED	81	78
COMPLETED	77	76
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Active	Vehicle	Total
Arm/Group Description	A-101 Topical Solution A-101 Topical Solution: A-101 Topical Solution	Vehicle A-101 Vehicle Solution: A-101 Vehicle Solution	Total of all reporting groups
Overall Participants	81	78	159
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.96 (18.09)	41.56 (17.42)	39.73 (17.8)
Sex: Female, Male (Count of Participants)
Female	48 59.3%	43 55.1%	91 57.2%
Male	33 40.7%	35 44.9%	68 42.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	13 16%	16 20.5%	29 18.2%
Not Hispanic or Latino	65 80.2%	55 70.5%	120 75.5%
Unknown or Not Reported	3 3.7%	7 9%	10 6.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.2%	0 0%	1 0.6%
Native Hawaiian or Other Pacific Islander	1 1.2%	1 1.3%	2 1.3%
Black or African American	1 1.2%	4 5.1%	5 3.1%
White	78 96.3%	70 89.7%	148 93.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	3 3.8%	3 1.9%
Region of Enrollment (participants) [Number]
United States	81 100%	78 100%	159 100%

Outcome Measures

1. Primary Outcome

Title	Physician's Wart Assessment
Description	Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length) A visible wart ≥ 6 mm in maximal diameter (or length)
Time Frame	Day 57

Outcome Measure Data

Analysis Population Description

Per-Protocol (PP)

Arm/Group Title	Active	Vehicle
Arm/Group Description	A-101 Topical Solution A-101 Topical Solution: A-101 Topical Solution	Vehicle A-101 Vehicle Solution: A-101 Vehicle Solution
Measure Participants	79	78
Mean (Standard Deviation) [score on a scale]	1.52 (1.06)	2.23 (0.66)

Adverse Events

Time Frame	78 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78)
Adverse Event Reporting Description	An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication. Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.
Arm/Group Title	Active		Vehicle
Arm/Group Description	A-101 Topical Solution A-101 Topical Solution: A-101 Topical Solution		Vehicle A-101 Vehicle Solution: A-101 Vehicle Solution
All Cause Mortality
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/78 (0%)
Serious Adverse Events
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		0/78 (0%)
Other (Not Including Serious) Adverse Events
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/81 (34.6%)		19/78 (24.4%)
Ear and labyrinth disorders
Tympanic Membrane Perforation	1/81 (1.2%)	1	0/78 (0%)	0
Gastrointestinal disorders
Constipation	0/81 (0%)	0	2/78 (2.6%)	2
Diarrhoea	1/81 (1.2%)	1	0/78 (0%)	0
Irritable Bowel Syndrome	1/81 (1.2%)	1	0/78 (0%)	0
Vomiting	1/81 (1.2%)	1	0/78 (0%)	0
General disorders
Application Site Pain	1/81 (1.2%)	1	0/78 (0%)	0
Immune system disorders
Food Allergy	0/81 (0%)	0	1/78 (1.3%)	1
Seasonal Allergy	1/81 (1.2%)	1	1/78 (1.3%)	1
Infections and infestations
Ear Infection	0/81 (0%)	0	1/78 (1.3%)	1
Eye Infection	0/81 (0%)	0	1/78 (1.3%)	1
Gastroenteritis Viral	2/81 (2.5%)	2	1/78 (1.3%)	1
Infection	1/81 (1.2%)	1	0/78 (0%)	0
Influenza	2/81 (2.5%)	2	0/78 (0%)	0
Localised Infection	0/81 (0%)	0	1/78 (1.3%)	1
Nasopharyngitis	5/81 (6.2%)	5	4/78 (5.1%)	4
Pneumonia	1/81 (1.2%)	1	0/78 (0%)	0
Post Operative Wound Infection	1/81 (1.2%)	1	0/78 (0%)	0
Salmonellosis	1/81 (1.2%)	1	0/78 (0%)	0
Sinusitis	0/81 (0%)	0	1/78 (1.3%)	1
Upper Respiratory Tract Infection	4/81 (4.9%)	4	4/78 (5.1%)	4
Urinary Tract Infection	0/81 (0%)	0	1/78 (1.3%)	1
Injury, poisoning and procedural complications
Foot Fracture	0/81 (0%)	0	1/78 (1.3%)	1
Injury	2/81 (2.5%)	2	0/78 (0%)	0
Investigations
Blood Lactate Dehydrogenase Increased	1/81 (1.2%)	1	0/78 (0%)	0
Hepatic Enzyme Increased	1/81 (1.2%)	1	0/78 (0%)	0
Liver Function Test Increased	1/81 (1.2%)	1	0/78 (0%)	0
Metabolism and nutrition disorders
Electrolyte Imbalance	1/81 (1.2%)	1	0/78 (0%)	0
Hyperlipidaemia	0/81 (0%)	0	1/78 (1.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/81 (1.2%)	1	0/78 (0%)	0
Back Pain	0/81 (0%)	0	1/78 (1.3%)	1
Coccydynia	0/81 (0%)	0	1/78 (1.3%)	1
Neck Pain	0/81 (0%)	0	1/78 (1.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Head and Neck	0/81 (0%)	0	1/78 (1.3%)	1
Nervous system disorders
Headache	2/81 (2.5%)	2	1/78 (1.3%)	1
Product Issues
Device Dislocation	0/81 (0%)	0	1/78 (1.3%)	1
Reproductive system and breast disorders
Ovarian Cyst Ruptured	1/81 (1.2%)	1	0/78 (0%)	0
Uterine Haemorrage	1/81 (1.2%)	1	0/78 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/81 (0%)	0	1/78 (1.3%)	1
Oropharyngeal Pain	1/81 (1.2%)	1	0/78 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis Contact	1/81 (1.2%)	1	0/78 (0%)	0
Pain of Skin	1/81 (1.2%)	1	0/78 (0%)	0
Skin Exfoliation	1/81 (1.2%)	1	0/78 (0%)	0
Skin Hyperpigmentation	1/81 (1.2%)	1	0/78 (0%)	0
Skin Hypopigmentation	2/81 (2.5%)	2	0/78 (0%)	0
Vascular disorders
Hypertension	2/81 (2.5%)	2	0/78 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.