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

• Sponsor: Aclaris Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03691831
• Collaborator: (none)
• Enrollment: 502
• Locations: 24
• Arms: 2
• Actual Duration (Months): 9.8
• Patients Per Site: 20.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

Condition or Disease	Intervention/Treatment	Phase
Common Wart	Drug: Active; Other: Vehicle	Phase 3

Detailed Description

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Study Design

• Study Type: Interventional
• Actual Enrollment: 502 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group StudyRandomized, Double-Blind, Vehicle-Controlled, Parallel Group Study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.
• Primary Purpose: Treatment
• Official Title: A Phase 3 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: Sep 13, 2018
• Actual Primary Completion Date: Apr 21, 2019
• Actual Study Completion Date: Jul 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active A-101 45% (Topical solution, hydrogen peroxide 45%)	Drug: Active; A-101 45% (hydrogen peroxide 45% topical solution); Other Names: hydrogen peroxide 45%
Placebo Comparator: Vehicle Topical solution, isopropyl alcohol and water	Other: Vehicle; Vehicle solution containing isopropyl alcohol and water; Other Names: isopropyl alcohol and sterile water

Outcome Measures

Primary Outcome Measures

1. The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60) [Day 60]

   The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Secondary Outcome Measures

1. Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137) [Day 137]

   Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

2. Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137) [Day 137]

   Mean Per-Subject Percent of all Warts that were Clear on the Physician Wart Assessment (PWA) scale between Active (A-101 45%) and Vehicle that are clear (PWA=0) at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

3. Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60) [Day 60]

   Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60. Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

4. Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts [Day 137]

   Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

2. Male or female ≥ 2 years old.

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

4. Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below:

5. Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm

6. Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts.

7. Be present for at least 4 weeks

8. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations

9. Not be in an intertriginous fold

10. Periungual, subungual, genital, anal, mosaic, plantar, flat and filiform warts are excluded from treatment and evaluation. If a subject has these types of warts, but also has warts that meet the inclusion criteria, the subject will NOT be excluded from the study.

11. Each common wart identified for treatment must have a PWA ≥ 2.

12. Subject's 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.

13. 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 the identified common warts or which exposes the subject to an unacceptable risk by study participation.

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

15. Subject must be the only individual in a household participating in the study.

Exclusion Criteria:

1. Subject has clinically atypical common warts.

2. Subject is immunocompromised (e.g., 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 6 months prior to Visit

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

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

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

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

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

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

12. 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:

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

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

15. Liquid nitrogen, electrodesiccation, curettage; 60 days

16. Hydrogen peroxide; 90 days

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

18. Retinoids; 90 days

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

20. Subject currently has or has had any of the following within the specified period prior to Visit 1 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:

21. Cutaneous malignancy; 180 days

22. Sunburn; currently

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

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

25. 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.

26. Participation in another therapeutic investigational drug/device trial in which administration of an investigational treatment occurred with 30 days prior to Visit 1.

27. Subject has an active malignancy.

28. Subjects is viewed by the Principal Investigator as not being able to complete the study.

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	92024-7700
4	Aclaris Investigational Site	San Diego	California	United States	92121
5	Aclaris Investigational Site	Denver	Colorado	United States	80210
6	Aclaris Investigational Site	Coral Gables	Florida	United States	33134
7	Aclaris Investigational Site	Miami	Florida	United States	33155
8	Aclaris Investigational Site	New Albany	Indiana	United States	47150
9	Aclaris Investigational Site	Rockville	Maryland	United States	20850
10	Aclaris Investigational Site	Quincy	Massachusetts	United States	02169
11	Aclaris Investigational Site	Saint Joseph	Missouri	United States	64506
12	Aclaris Investigational Site	Omaha	Nebraska	United States	68144
13	Aclaris Investigational Site	Rochester	New York	United States	14623
14	Aclaris Investigational Site	Raleigh	North Carolina	United States	27612
15	Aclaris Investigational Site	Beachwood	Ohio	United States	44122
16	Aclaris Investigational Site	Upper Saint Clair	Pennsylvania	United States	15241
17	Aclaris Investigational Site	Anderson	South Carolina	United States	29621
18	Aclaris Investigational Site	Knoxville	Tennessee	United States	37922
19	Aclaris Investigational Site	Nashville	Tennessee	United States	37215
20	Aclaris Investigational Site	Arlington	Texas	United States	76011
21	Aclaris Investigational Site	College Station	Texas	United States	77845
22	Aclaris Investigational Site	Houston	Texas	United States	77004
23	Aclaris Investigational Site	Lynchburg	Virginia	United States	24501
24	Aclaris Investigational Site	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Aclaris Therapeutics, Inc.

Investigators

• Study Director: Judy Schynder, Aclaris Therapeutics

Study Documents (Full-Text)

• Study Protocol - Feb 14, 2019
• Statistical Analysis Plan - Sep 26, 2019
• Informed Consent Form - Jul 27, 2018

More Information

Publications

None provided.

• Responsible Party: Aclaris Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03691831
• Other Study ID Numbers: A-101-WART-302
• First Posted: Oct 2, 2018
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 1, 2020

• 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; Hydrogen Peroxide

Study Results

Participant Flow

Arm/Group Title	Active	Vehicle
Arm/Group Description	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Period Title: Overall Study
STARTED	251	251
COMPLETED	224	220
NOT COMPLETED	27	31

Baseline Characteristics

Arm/Group Title	Active	Vehicle	Total
Arm/Group Description	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water	Total of all reporting groups
Overall Participants	251	251	502
Age (Count of Participants)
<=18 years	75 29.9%	70 27.9%	145 28.9%
Between 18 and 65 years	169 67.3%	168 66.9%	337 67.1%
>=65 years	7 2.8%	13 5.2%	20 4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.1 (17.80)	31.7 (17.33)	31.4 (17.55)
Sex: Female, Male (Count of Participants)
Female	104 41.4%	111 44.2%	215 42.8%
Male	147 58.6%	140 55.8%	287 57.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	23 9.2%	35 13.9%	58 11.6%
Not Hispanic or Latino	206 82.1%	199 79.3%	405 80.7%
Unknown or Not Reported	22 8.8%	17 6.8%	39 7.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%	0 0%	1 0.2%
Asian	5 2%	2 0.8%	7 1.4%
Native Hawaiian or Other Pacific Islander	2 0.8%	0 0%	2 0.4%
Black or African American	13 5.2%	13 5.2%	26 5.2%
White	228 90.8%	230 91.6%	458 91.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 0.8%	6 2.4%	8 1.6%
Region of Enrollment (participants) [Number]
United States	251 100%	251 100%	502 100%
Fitzpatrick Skin Type (Count of Participants)
I - Always Burns	9 3.6%	14 5.6%	23 4.6%
II - Burns Easily	93 37.1%	91 36.3%	184 36.7%
III - Burns Moderately	87 34.7%	83 33.1%	170 33.9%
IV - Burns Minimally	42 16.7%	41 16.3%	83 16.5%
V - Rarely Burns	13 5.2%	14 5.6%	27 5.4%
VI - Never Burns	7 2.8%	8 3.2%	15 3%
Prior Treatment of any Wart Treated (Count of Participants)
Yes	114 45.4%	112 44.6%	226 45%
No	137 54.6%	139 55.4%	276 55%
Total Warts Treated (Count of Participants)
1	126 50.2%	142 56.6%	268 53.4%
2	68 27.1%	49 19.5%	117 23.3%
3	22 8.8%	18 7.2%	40 8%
4	13 5.2%	14 5.6%	27 5.4%
5	10 4%	10 4%	20 4%
6	12 4.8%	18 7.2%	30 6%
Time Since First Appearance of Most Recent Wart Treated (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	1726.7 (2210.95)	1670.2 (2041.81)	1698.6 (2126.62)
Time since First Appearance of Least Recent Wart Treated (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	1926.2 (2298.39)	1780.0 (2037.01)	1853.5 (2171.47)
Thickness of "Largest" Wart Treated (millimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters]	1.49 (0.741)	1.50 (0.752)	1.49 (0.746)
Longest Axis of "Largest" Wart Treated (millimeter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeter]	5.1 (1.54)	5.1 (1.55)	5.1 (1.55)

Outcome Measures

1. Primary Outcome

Title	The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)
Description	The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.
Time Frame	Day 60

Outcome Measure Data

Analysis Population Description

The study's primary endpoint was to evaluate the amount of patients achieving a clearance of all baseline WARTS. Patients were stratified by the amount of WARTS at Baseline.

Arm/Group Title	Active	Vehicle
Arm/Group Description	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Measure Participants	251	251
Warts at Baseline - All	33 13.1%	8 3.2%
Warts at Baseline - 1	19 7.6%	4 1.6%
Warts at Baseline - 2	9 3.6%	0 0%
Warts at Baseline - 3	3 1.2%	0 0%
Warts at Baseline - >3	2 0.8%	4 1.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active, Vehicle
	Comments	A summary of the wart clearance at Visit 10.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.80
	Confidence Interval	(2-Sided) 95%; 2.14 to 10.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)
Description	Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.
Time Frame	Day 137

Outcome Measure Data

Analysis Population Description

The study's primary endpoint was to evaluate the amount of patients achieving a clearance of all baseline WARTS. Patients were stratified by the amount of WARTS at Baseline.

Arm/Group Title	Active	Vehicle
Arm/Group Description	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Measure Participants	251	251
Warts at Baseline - All	56 22.3%	25 10%
Warts at Baseline - 1	29 11.6%	13 5.2%
Warts at Baseline - 2	12 4.8%	2 0.8%
Warts at Baseline - 3	5 2%	2 0.8%
Warts at Baseline - >3	10 4%	8 3.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active, Vehicle
	Comments	P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.71
	Confidence Interval	(2-Sided) 95%; 1.61 to 4.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)
Description	Mean Per-Subject Percent of all Warts that were Clear on the Physician Wart Assessment (PWA) scale between Active (A-101 45%) and Vehicle that are clear (PWA=0) at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Time Frame	Day 137

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Vehicle
Arm/Group Description	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Measure Participants	251	251
Mean (Standard Deviation) [percentage of warts cleared]	27.7 (2.30)	12.2 (2.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active, Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	15.44
	Confidence Interval	(2-Sided) 95%; 9.0 to 21.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)
Description	Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60. Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Time Frame	Day 60

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active	Vehicle
Arm/Group Description	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Measure Participants	126	142
Count of Participants [Participants]	19 7.6%	4 1.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active, Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	5.20
	Confidence Interval	(2-Sided) 95%; 1.76 to 15.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts
Description	Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Time Frame	Day 137

Outcome Measure Data

Analysis Population Description

A median was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.

Arm/Group Title	Active	Vehicle
Arm/Group Description	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Measure Participants	251	251
Median (95% Confidence Interval) [days]	113	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active, Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	3.33
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	137 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	Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution		Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
All Cause Mortality
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/251 (0%)		0/251 (0%)
Serious Adverse Events
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/251 (0.4%)		2/251 (0.8%)
Gastrointestinal disorders
Intestinal obstruction	1/251 (0.4%)	1	0/251 (0%)	0
diverticulitis	0/251 (0%)	0	1/251 (0.4%)	1
Renal and urinary disorders
Stag horn calculus	0/251 (0%)	0	1/251 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	154/251 (61.4%)		61/251 (24.3%)
Ear and labyrinth disorders
Ear Pain	1/251 (0.4%)		0/251 (0%)
Eye disorders
Blepharitis	1/251 (0.4%)		0/251 (0%)
Cataract	1/251 (0.4%)		0/251 (0%)
Gastrointestinal disorders
Vomiting	1/251 (0.4%)		2/251 (0.8%)
Intestinal obstruction	1/251 (0.4%)		0/251 (0%)
Food poisoning	0/251 (0%)		1/251 (0.4%)
General disorders
Application site dermatitis	3/251 (1.2%)		1/251 (0.4%)
Application site discoloration	4/251 (1.6%)		1/251 (0.4%)
Application site dryness	2/251 (0.8%)		0/251 (0%)
Application site erosion	13/251 (5.2%)		4/251 (1.6%)
Application site erythema	26/251 (10.4%)		10/251 (4%)
Application site irritation	5/251 (2%)		0/251 (0%)
Application site edema	10/251 (4%)		5/251 (2%)
Application site pain	107/251 (42.6%)		5/251 (2%)
Application site pallor	44/251 (17.5%)		0/251 (0%)
Application site paresthesia	3/251 (1.2%)		3/251 (1.2%)
Application site pruritus	23/251 (9.2%)		3/251 (1.2%)
Application site scab	20/251 (8%)		1/251 (0.4%)
Application site haemorrhage	1/251 (0.4%)		0/251 (0%)
Application site hypoaesthesia	1/251 (0.4%)		0/251 (0%)
Application site swelling	1/251 (0.4%)		0/251 (0%)
Application site ulcer	1/251 (0.4%)		0/251 (0%)
Application site vesicles	1/251 (0.4%)		0/251 (0%)
Feeling cold	1/251 (0.4%)		0/251 (0%)
Pain	1/251 (0.4%)		0/251 (0%)
Pyrexia	1/251 (0.4%)		2/251 (0.8%)
Immune system disorders
Seasonal allergy	0/251 (0%)		1/251 (0.4%)
Infections and infestations
Nasopharyngitis	7/251 (2.8%)		3/251 (1.2%)
Sinusitis	3/251 (1.2%)		3/251 (1.2%)
Upper respiratory tract infection	11/251 (4.4%)		6/251 (2.4%)
Influenza	2/251 (0.8%)		5/251 (2%)
Pharyngitis streptococcal	1/251 (0.4%)		3/251 (1.2%)
Viral upper respiratory tract infection	2/251 (0.8%)		2/251 (0.8%)
Bronchitis	1/251 (0.4%)		1/251 (0.4%)
Atypical pneumonia	1/251 (0.4%)		0/251 (0%)
Otitis media	1/251 (0.4%)		1/251 (0.4%)
Urinary tract infection	1/251 (0.4%)		0/251 (0%)
Ear Infection	0/251 (0%)		1/251 (0.4%)
Gastrointestinal viral infection	0/251 (0%)		1/251 (0.4%)
Herpes zoster	0/251 (0%)		1/251 (0.4%)
Laryngitis	0/251 (0%)		1/251 (0.4%)
Pharyngitis	1/251 (0.4%)		0/251 (0%)
Injury, poisoning and procedural complications
Contusion	2/251 (0.8%)		0/251 (0%)
Arthropod bite	1/251 (0.4%)		0/251 (0%)
Joint dislocation	1/251 (0.4%)		0/251 (0%)
Ligament sprain	1/251 (0.4%)		0/251 (0%)
Muscle strain	1/251 (0.4%)		0/251 (0%)
Radius fracture	1/251 (0.4%)		0/251 (0%)
Face Injury	0/251 (0%)		1/251 (0.4%)
Wrist Fracture	0/251 (0%)		1/251 (0.4%)
Hand Fracture	0/251 (0%)		1/251 (0.4%)
Metabolism and nutrition disorders
Hyperlipidaemia	1/251 (0.4%)		0/251 (0%)
Musculoskeletal and connective tissue disorders
Bursitis	1/251 (0.4%)		0/251 (0%)
Muscle spasms	1/251 (0.4%)		0/251 (0%)
Pain in extremity	1/251 (0.4%)		0/251 (0%)
Spinal osteoarthritis	1/251 (0.4%)		0/251 (0%)
Back pain	0/251 (0%)		1/251 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	1/251 (0.4%)		0/251 (0%)
Nervous system disorders
Headache	2/251 (0.8%)		0/251 (0%)
Burning sensation	1/251 (0.4%)		0/251 (0%)
Migraine	0/251 (0%)		1/251 (0.4%)
Syncope	0/251 (0%)		1/251 (0.4%)
Presyncope	0/251 (0%)		1/251 (0.4%)
Psychiatric disorders
Anxiety	1/251 (0.4%)		0/251 (0%)
Attention deficit/hyperactivity disorder	0/251 (0%)		1/251 (0.4%)
Renal and urinary disorders
Nephrolithiasis	0/251 (0%)		2/251 (0.8%)
Stag horn calculus	0/251 (0%)		1/251 (0.4%)
Respiratory, thoracic and mediastinal disorders
Sinus congestion	1/251 (0.4%)		2/251 (0.8%)
Asthma	1/251 (0.4%)		0/251 (0%)
Sleep apnea syndrome	1/251 (0.4%)		0/251 (0%)
Cough	0/251 (0%)		1/251 (0.4%)
Dyspnoea	0/251 (0%)		1/251 (0.4%)
Nasal congestion	0/251 (0%)		1/251 (0.4%)
Oropharyngeal pain	0/251 (0%)		1/251 (0.4%)
Upper respiratory tract congestion	0/251 (0%)		1/251 (0.4%)
Skin and subcutaneous tissue disorders
Eczema	1/251 (0.4%)		0/251 (0%)
Nail discolouration	1/251 (0.4%)		0/251 (0%)
Rash	1/251 (0.4%)		0/251 (0%)
Skin lesion	1/251 (0.4%)		0/251 (0%)
Dermatitis	0/251 (0%)		1/251 (0.4%)
Dermatitis contact	0/251 (0%)		1/251 (0.4%)
Pityriasis alba	0/251 (0%)		1/251 (0.4%)
Vascular disorders
Hypertension	2/251 (0.8%)		1/251 (0.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.