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

• Sponsor: Aclaris Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03687372
• Collaborator: (none)
• Enrollment: 503
• Locations: 24
• Arms: 2
• Actual Duration (Months): 11.6
• Patients Per Site: 21
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Common Wart	Drug: A-101; 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: 503 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 17, 2018
• Actual Primary Completion Date: Jun 20, 2019
• Actual Study Completion Date: Sep 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A-101 topical solution	Drug: A-101; hydrogen peroxide topical solution 45%; Other Names: hydrogen peroxide 45%
Other: Vehicle topical solution	Other: vehicle; vehicle as a topical solution; 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 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 ≥ 1 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.

13. Subject is in good general health and free of any known disease state or physical condition.

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 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:

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

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

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

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

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

1. 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:

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

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

• Liquid nitrogen, electrodesiccation, curettage; 60 days

• Hydrogen peroxide; 90 days

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

• Retinoids; 90 days

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

1. 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:

• Cutaneous malignancy; 180 days

• Sunburn; currently

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

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

2. 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.

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

4. Subject has an active malignancy.

5. 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	Mobile	Alabama	United States	36608
2	Aclaris Investigational Site	Hot Springs	Arkansas	United States	71913
3	Aclaris Investigational Site	Fountain Valley	California	United States	92708
4	Aclaris Investigational site	San Diego	California	United States	92123
5	Aclaris Investigational Site	Aventura	Florida	United States	33180
6	Aclaris Investigational Site	Jacksonville	Florida	United States	32256
7	Aclaris Investigational Site	Miami	Florida	United States	33144
8	Aclaris Investigational Site	Ocala	Florida	United States	34470
9	Aclaris Investigational Site	Newnan	Georgia	United States	30263
10	Aclaris Investigational Site	Indianapolis	Indiana	United States	46256
11	Aclaris Investigational Site	Louisville	Kentucky	United States	40241
12	Aclaris Investigational Site	Chestnut Hill	Massachusetts	United States	02467
13	Aclaris Investigational Site	Warren	Michigan	United States	48088
14	Aclaris Investigational Site	Fridley	Minnesota	United States	55432
15	Aclaris Investigational Site	Las Vegas	Nevada	United States	89148
16	Aclaris Investigational Site	Verona	New Jersey	United States	07044
17	Aclaris Investigational Site	Broomall	Pennsylvania	United States	19008
18	Aclaris Investigational Site	Fort Washington	Pennsylvania	United States	19034
19	Aclaris Investigational Site	Charleston	South Carolina	United States	29407
20	Aclaris Investigational Site	Greenville	South Carolina	United States	29607
21	Aclaris Investigational Site	Austin	Texas	United States	78759
22	Aclaris Investigational Site	Pflugerville	Texas	United States	78660
23	Aclaris Investigational Site	San Antonio	Texas	United States	78213
24	Aclaris Investigational Site	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Aclaris Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Jun 5, 2019
• Informed Consent Form: ICF (ages 12-17) - Jul 27, 2018
• Study Protocol - Feb 14, 2019
• Informed Consent Form: Main ICF - Jul 27, 2018
• Informed Consent Form: ICF (ages 7-11) - Jul 27, 2018
• Informed Consent Form: PCF Photography - Oct 29, 2018

More Information

Publications

None provided.

• Responsible Party: Aclaris Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03687372
• Other Study ID Numbers: A-101-WART-301
• First Posted: Sep 27, 2018
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aclaris Therapeutics, Inc.: common warts
• Additional relevant MeSH terms: Warts; Hydrogen Peroxide

Study Results

Participant Flow

Arm/Group Title	Hydrogen Peroxide 45% A-101	Isopropyl Alcohol and Water 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	254	249
COMPLETED	237	210
NOT COMPLETED	17	39

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	254	249	503
Age (Count of Participants)
<=18 years	92 36.2%	96 38.6%	188 37.4%
Between 18 and 65 years	155 61%	148 59.4%	303 60.2%
>=65 years	7 2.8%	5 2%	12 2.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.0 (18.21)	29.4 (18.30)	30.2 (18.25)
Sex: Female, Male (Count of Participants)
Female	142 55.9%	137 55%	279 55.5%
Male	112 44.1%	112 45%	224 44.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 10.6%	45 18.1%	72 14.3%
Not Hispanic or Latino	211 83.1%	193 77.5%	404 80.3%
Unknown or Not Reported	16 6.3%	11 4.4%	27 5.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.8%	0 0%	2 0.4%
Asian	8 3.1%	4 1.6%	12 2.4%
Native Hawaiian or Other Pacific Islander	1 0.4%	1 0.4%	2 0.4%
Black or African American	4 1.6%	4 1.6%	8 1.6%
White	238 93.7%	236 94.8%	474 94.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.4%	4 1.6%	5 1%
Region of Enrollment (participants) [Number]
United States	254 100%	249 100%	503 100%
Fitzpatrick Skin Type (Count of Participants)
I - Always Burns	15 5.9%	10 4%	25 5%
II - Burns Easily	94 37%	79 31.7%	173 34.4%
III - Burns Moderately	92 36.2%	110 44.2%	202 40.2%
IV - Burns Minimally	40 15.7%	41 16.5%	81 16.1%
V - Rarely Burns	11 4.3%	9 3.6%	20 4%
VI - Never Burns	2 0.8%	0 0%	2 0.4%
Prior Treatment of any Wart Treated (Count of Participants)
Yes	124 48.8%	118 47.4%	242 48.1%
No	130 51.2%	131 52.6%	261 51.9%
Total Warts Treated (Count of Participants)
1	162 63.8%	141 56.6%	303 60.2%
2	37 14.6%	49 19.7%	86 17.1%
3	28 11%	22 8.8%	50 9.9%
4	10 3.9%	15 6%	25 5%
5	5 2%	9 3.6%	14 2.8%
6	12 4.7%	13 5.2%	25 5%
Time Since First Appearance of Most Recent Wart Treated (Days) (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	1306.0 (1852.41)	1268.2 (1729.51)	1287.3 (1791.06)
Time since First Appearance of Least Recent Wart Treated (Days) (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	1514.3 (2151.39)	1404.2 (1734.64)	1459.9 (1955.46)
Longest Axis of "Largest" Wart Treated (mm) (millimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters]	5.3 (1.54)	5.1 (1.53)	5.2 (1.53)
Thickness of "Largest" Wart Treated (mm) (millimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters]	1.52 (0.743)	1.51 (0.715)	1.51 (0.728)

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	Hydrogen Peroxide 45% A-101	Isopropyl Alcohol and Water 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	254	249
Warts at Baseline - All	40 15.7%	13 5.2%
Warts at Baseline - 1	33 13%	10 4%
Warts at Baseline - 2	2 0.8%	1 0.4%
Warts at Baseline - 3	2 0.8%	1 0.4%
Warts at Baseline - >3	3 1.2%	1 0.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydrogen Peroxide 45% A-101, Isopropyl Alcohol and Water Vehicle
	Comments	A summary of the wart clearance at Visit 10.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	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	Mean Difference (Final Values)
	Estimated Value	3.22
	Confidence Interval	(2-Sided) 95%; 1.67 to 6.22
	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 secondary 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 13 (Day 137). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale.

Arm/Group Title	Hydrogen Peroxide 45% A-101	Isopropyl Alcohol and Water Vehicle
Arm/Group Description	topical solution A-101: hydrogen peroxide topical solution 45%	topical solution vehicle: vehicle as a topical solution
Measure Participants	254	249
Warts at Baseline - All	57 22.4%	29 11.6%
Warts at Baseline - 1	46 18.1%	21 8.4%
Warts at Baseline - 2	3 1.2%	1 0.4%
Warts at Baseline - 3	3 1.2%	1 0.4%
Warts at Baseline - >3	5 2%	6 2.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydrogen Peroxide 45% A-101, Isopropyl Alcohol and Water Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments	P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.
Statistical Test of Hypothesis	p-Value	0.0024
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.14
	Confidence Interval	(2-Sided) 95%; 1.30 to 3.52
	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 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

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale.

Arm/Group Title	Hydrogen Peroxide 45% A-101	Isopropyl Alcohol and Water 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	254	249
Mean (Standard Deviation) [percentage of all warts cleared]	28.6 (2.38)	14.5 (2.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydrogen Peroxide 45% A-101, Isopropyl Alcohol and Water 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	14.12
	Confidence Interval	(2-Sided) 95%; 7.5 to 20.8
	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	Hydrogen Peroxide 45% A-101	Isopropyl Alcohol and Water 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	162	141
Count of Participants [Participants]	33 13%	10 4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydrogen Peroxide 45% A-101, Isopropyl Alcohol and Water Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.22
	Confidence Interval	(2-Sided) 95%; 1.55 to 6.65
	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	Hydrogen Peroxide 45% A-101	Isopropyl Alcohol and Water 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	254	249
Median (95% Confidence Interval) [days]	84	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hydrogen Peroxide 45% A-101, Isopropyl Alcohol and Water 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	2.56
	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	0/254 (0%)		0/249 (0%)
Serious Adverse Events
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/254 (0.4%)		1/249 (0.4%)
Injury, poisoning and procedural complications
Animal bite	1/254 (0.4%)	1	0/249 (0%)	0
Psychiatric disorders
Suicide attempt	0/254 (0%)	0	1/249 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Active		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	153/254 (60.2%)		67/249 (26.9%)
Ear and labyrinth disorders
Ear pain	0/254 (0%)	0	1/249 (0.4%)	1
Ear Swelling	1/254 (0.4%)	1	0/249 (0%)	0
Eye disorders
Blepharitis	0/254 (0%)	0	1/249 (0.4%)	1
Cataract	1/254 (0.4%)	1	0/249 (0%)	0
Eye pruritus	0/254 (0%)	0	1/249 (0.4%)	1
Eye swelling	0/254 (0%)	0	1/249 (0.4%)	1
Gastrointestinal disorders
Abdominal pain	1/254 (0.4%)	1	0/249 (0%)	0
Abdominal pain upper	0/254 (0%)	0	1/249 (0.4%)	1
Aphthous ulcer	0/254 (0%)	0	1/249 (0.4%)	1
Diarrhoea	4/254 (1.6%)	4	1/249 (0.4%)	1
Nausea	1/254 (0.4%)	1	0/249 (0%)	0
Salivary gland enlargement	1/254 (0.4%)	1	0/249 (0%)	0
Vomiting	3/254 (1.2%)	3	0/249 (0%)	0
General disorders
Application site discolouration	1/254 (0.4%)	1	0/249 (0%)	0
Application site dryness	2/254 (0.8%)	2	0/249 (0%)	0
Application site dysaesthesia	1/254 (0.4%)	1	0/249 (0%)	0
Application site erosion	16/254 (6.3%)	16	3/249 (1.2%)	3
Application site erythema	44/254 (17.3%)	44	5/249 (2%)	5
Application site fissure	2/254 (0.8%)	2	0/249 (0%)	0
Application site haemorrhage	0/254 (0%)	0	2/249 (0.8%)	2
Application site hypoaesthesia	0/254 (0%)	0	1/249 (0.4%)	1
Application site injury	0/254 (0%)	0	2/249 (0.8%)	2
Application site irritation	3/254 (1.2%)	3	0/249 (0%)	0
Application site oedema	10/254 (3.9%)	10	0/249 (0%)	0
Application site pain	80/254 (31.5%)	80	6/249 (2.4%)	6
Application site pallor	3/254 (1.2%)	3	0/249 (0%)	0
Application site paraesthesia	0/254 (0%)	0	1/249 (0.4%)	1
Application site pruritus	26/254 (10.2%)	26	6/249 (2.4%)	6
Application site reaction	3/254 (1.2%)	3	0/249 (0%)	0
Application site scab	50/254 (19.7%)	50	1/249 (0.4%)	1
Application site ulcer	2/254 (0.8%)	2	0/249 (0%)	0
Application site vesicles	3/254 (1.2%)	3	0/249 (0%)	0
Fatigue	0/254 (0%)	0	1/249 (0.4%)	1
Influenza like illness	0/254 (0%)	0	1/249 (0.4%)	1
Medical device pain	0/254 (0%)	0	1/249 (0.4%)	1
Pain	0/254 (0%)	0	1/249 (0.4%)	1
Pyrexia	0/254 (0%)	0	1/249 (0.4%)	1
Immune system disorders
Allergy to arthropod sting	1/254 (0.4%)	1	0/249 (0%)	0
Seasonal allergy	1/254 (0.4%)	1	1/249 (0.4%)	1
Infections and infestations
Cellulitis	1/254 (0.4%)	1	2/249 (0.8%)	2
Ear infection	1/254 (0.4%)	1	0/249 (0%)	0
Herpes zoster	0/254 (0%)	0	1/249 (0.4%)	1
Influenza	2/254 (0.8%)	2	4/249 (1.6%)	4
Nasopharyngitis	8/254 (3.1%)	8	12/249 (4.8%)	12
Otitis media	0/254 (0%)	0	1/249 (0.4%)	1
Otitis media acute	1/254 (0.4%)	1	0/249 (0%)	0
Pharyngitis streptococcal	1/254 (0.4%)	1	5/249 (2%)	5
Pneumonia	0/254 (0%)	0	1/249 (0.4%)	1
Sinusitis	2/254 (0.8%)	2	6/249 (2.4%)	6
Upper respiratory tract infection	8/254 (3.1%)	8	12/249 (4.8%)	12
Urinary tract infection	1/254 (0.4%)	1	0/249 (0%)	0
Viral upper respiratory tract infection	1/254 (0.4%)	1	0/249 (0%)	0
Injury, poisoning and procedural complications
Animal bite	1/254 (0.4%)	1	0/249 (0%)	0
Burns first degree	0/254 (0%)	0	1/249 (0.4%)	1
Concussion	1/254 (0.4%)	1	0/249 (0%)	0
Ligament rupture	1/254 (0.4%)	1	0/249 (0%)	0
Limb injury	1/254 (0.4%)	1	0/249 (0%)	0
Meniscus injury	1/254 (0.4%)	1	0/249 (0%)	0
Muscle strain	1/254 (0.4%)	1	0/249 (0%)	0
Procedural pain	1/254 (0.4%)	1	2/249 (0.8%)	2
Skin laceration	1/254 (0.4%)	1	0/249 (0%)	0
Tibia fracture	1/254 (0.4%)	1	0/249 (0%)	0
Traumatic haematoma	0/254 (0%)	0	1/249 (0.4%)	1
Metabolism and nutrition disorders
Vitamin D deficiency	1/254 (0.4%)	1	0/249 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/254 (0.4%)	1	1/249 (0.4%)	1
Back pain	2/254 (0.8%)	2	0/249 (0%)	0
Myalgia	0/254 (0%)	0	1/249 (0.4%)	1
Nervous system disorders
Headache	1/254 (0.4%)	1	2/249 (0.8%)	2
Migraine	2/254 (0.8%)	2	0/249 (0%)	0
Sinus headache	0/254 (0%)	0	1/249 (0.4%)	1
Psychiatric disorders
Depression	0/254 (0%)	0	1/249 (0.4%)	1
Major depression	0/254 (0%)	0	1/249 (0.4%)	1
Suicide attempt	0/254 (0%)	0	1/249 (0.4%)	1
Reproductive system and breast disorders
Varicocele	1/254 (0.4%)	1	0/249 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/254 (0.4%)	1	0/249 (0%)	0
Nasal congestion	1/254 (0.4%)	1	0/249 (0%)	0
Oropharyngeal pain	0/254 (0%)	0	5/249 (2%)	5
Sleep apnoea syndrome	1/254 (0.4%)	1	0/249 (0%)	0
Skin and subcutaneous tissue disorders
Acne	1/254 (0.4%)	1	0/249 (0%)	0
Erythema	1/254 (0.4%)	1	0/249 (0%)	0
Nail dystrophy	1/254 (0.4%)	1	0/249 (0%)	0
Onycholysis	1/254 (0.4%)	1	0/249 (0%)	0
Psoriasis	1/254 (0.4%)	1	0/249 (0%)	0
Rash	0/254 (0%)	0	1/249 (0.4%)	1
Skin exfoliation	1/254 (0.4%)	1	0/249 (0%)	0
Urticaria	0/254 (0%)	0	1/249 (0.4%)	1
Surgical and medical procedures
Micrographic skin surgery	0/254 (0%)	0	1/249 (0.4%)	1
Vascular disorders
Hypertension	1/254 (0.4%)	1	0/249 (0%)	0

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.