A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris

• Sponsor: Actavis Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02267746
• Collaborator: (none)
• Enrollment: 893
• Locations: 15
• Arms: 3
• Duration (Months): 3
• Patients Per Site: 59.5
• Patients Per Site Per Month: 19.7

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Tazarotene (Fabior™); Drug: Tazarotene (Actavis); Drug: Vehicle foam	Phase 3

Detailed Description

Although topical retinoids have been individually used to successfully treat acne vulgaris, Fabior™ (Tazarotene) Foam, 0.1% is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis has developed a generic formulation of Tazarotene Foam, 0.1%, and the current study is designed to evaluate the safety and efficacy of this formulation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 893 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Safety and Therapeutic Equivalence of a Generic Tazarotene Foam 0.1%(Actavis) and the Reference Listed Fabior™(Tazarotene Foam, 0.1%) (Stiefel Laboratories, Inc.) in Treatment of Subjects With Acne Vulgaris
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fabior™(tazarotene) Reference listed drug: Fabior™ 0.1% foam (Stiefel)	Drug: Tazarotene (Fabior™)
Experimental: Tazarotene Tazarotene 0/1% foam (Actavis)	Drug: Tazarotene (Actavis)
Placebo Comparator: Vehicle foam Foam vehicle of the test product (Actavis)	Drug: Vehicle foam

Outcome Measures

Primary Outcome Measures

1. Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts [Mean percent change from baseline to Week 12]

   For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e., the lines around the nostrils and under the nostrils) and all mucus membranes.

2. Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts [Mean percent change from baseline to Week 12]

   Estimates of mean percent change from baseline for non-inflammatory lesions for the Test and Reference treatment.

Secondary Outcome Measures

1. The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment [IGA score at Week 12 compared to baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Healthy male or nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.

Informed Consent/Assent: Subjects ages 12 to 17 years inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.

Subjects must have a minimum ≥ 30 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 25 inflammatory lesions (i.e., papules and pustules) AND no cystic lesions and only up to 1 facial nodular lesion (less than or equal to 5 mm) on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e. the lines around the nostrils and under the nostrils) and all mucus membranes. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).

Subjects must have a severity grade 3, or 4 as per the Investigator's Global Assessment (IGA) (Section 6.2).

Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period for acne vulgaris, other than the Investigational Product.

Female Subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), must have a negative urine pregnancy test (with sensitivity down to at least 50mIU/ml hCG) within 2 weeks prior to baseline.

Female Subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), must be willing to use an acceptable form of birth control from the day of the first dose administration.. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months); NuvaRing® (vaginal contraceptive); Implanon™ (contraceptive implant) double barrier methods (e.g. condom and spermicide); IUD, or abstinence with a 2nd acceptable method of birth control should the Subject become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control.

All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration. Abstinence is an acceptable method of birth control for males.

Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

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Exclusion Criteria:

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Subjects with a history of hypersensitivity or allergy to tazarotene and its excipients, and/or any of the study medication ingredients.

Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris. Such conditions include, but are not limited to the following: auto immune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneform eruptions caused by make-up, medication, facial psoriasis and facial eczema, squamous cell carcinoma, steroid folliculitis, or bacterial folliculitis).

Subjects who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.

Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.

Subjects who have used any of the following within 6 months prior to baseline or use during the study:

1. oral retinoids (e.g. Accutane®)

2. therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).

Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.

Subjects who use androgen receptor blockers (such as spironolactone or flutamide) will be excluded from study participation.

Subjects who have had cosmetic procedures (e.g., facials, wax depilation) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study.

Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.

Subjects who have had laser therapy, electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 180 days prior to study entry.

Subjects who have used any of the following procedures on the face within 1 month prior to baseline or during the study:

1. cryodestruction or chemodestruction,

2. dermabrasion,

3. photodynamic therapy,

4. acne surgery,

5. intralesional steroids, or

6. X-ray therapy.

Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:

1. systemic corticosteroids (including intranasal and inhaled corticosteroids)

2. systemic antibiotics,

3. systemic treatment for acne vulgaris (other than oral retinoids which need a 6-month washout), or

4. systemic anti-inflammatory agents.

Subjects who have used any of the following treatments within 14 days prior to baseline or during the study:

1. topical steroids,

2. topical retinoids including over-the-counter preparations,

3. α-hydroxy/glycolic acid

4. topical anti-inflammatory agents, or

5. topical antibiotics.

Subjects who have started hormonal therapy or changed the dosage of their hormonal therapy within 3 months prior to baseline will be excluded from study participation. The dosage and frequency of use of any hormonal therapy started greater than 3 months prior to baseline must remain unchanged throughout the study (Visit 1 through Visit 4). Hormonal treatments include, but are not limited to, estrogenic and progestational agents such as birth control pills.

Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.

Subjects with current facial sunburn at baseline or subjects who will have excessive use of tanning booths, sunbathing, or excessive exposure to the sun during the study.

Subjects who will engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.

Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, Subjects who have any malignancy of the skin of the facial area will be excluded.

Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to cannabinoids, cocaine and barbiturates).

Subjects who have had general anesthesia for any reason and subjects who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation.

Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an Investigational Drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.

Subjects who have been previously enrolled in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Encino	California	United States	91436
2	Center for Dermatology Clinical Research	Fremont	California	United States	94538
3	Moore Clinical Research	Brandon	Florida	United States	33511
4	LCC Medical Research Institute	Miami	Florida	United States	33126
5	International Dermatology Research	Miami	Florida	United States	33144
6	FXM Research Corp	Miami	Florida	United States	33175
7	FXM Research Miramar	Miramar	Florida	United States	33027
8	Moore Clinical Research	Tampa	Florida	United States	33609
9	Moore Clinical Research	Tampa	Florida	United States	33618
10	Atlantic Clinical Research Collaborative	Wellington	Florida	United States	33414
11	Omega Medical Research	Warwick	Rhode Island	United States	02886
12	Research Across America	Dallas	Texas	United States	75234
13	Research Across America	Plano	Texas	United States	75093
14	Dermatology Research Center	Salt Lake City	Utah	United States	84117
15	FXM International	Belize City		Belize

Sponsors and Collaborators

• Actavis Inc.

Investigators

• Study Director: Keri Winkler, Akesis, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Actavis Inc.
• ClinicalTrials.gov Identifier: NCT02267746
• Other Study ID Numbers: WAT 14-1096
• First Posted: Oct 17, 2014
• Last Update Posted: Jun 12, 2020
• Last Verified: May 1, 2020

• Additional relevant MeSH terms: Acne Vulgaris; Nicotinic Acids; Tazarotene

Study Results

Participant Flow

Pre-assignment Detail	893 subjects were randomized and analyzed; 869 qualified for the mITT population and 758 for the PP population.

Arm/Group Title	Test	Reference	Vehicle
Arm/Group Description	Tazarotene 0.1% foam (Actavis LLC)	Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle foam of the test product (Actavis LLC)
Period Title: Overall Study
STARTED	298	296	299
COMPLETED	277	274	278
NOT COMPLETED	21	22	21

Baseline Characteristics

Arm/Group Title	Test	Reference	Vehicle	Total
Arm/Group Description	Tazarotene 0.1% foam (Actavis LLC)	Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle foam of the test product (Actavis LLC)	Total of all reporting groups
Overall Participants	292	288	294	874
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.5 (7.76)	21.1 (7.26)	21.0 (7.03)	21.2 (7.35)
Sex: Female, Male (Count of Participants)
Female	113 38.7%	107 37.2%	107 36.4%	327 37.4%
Male	179 61.3%	181 62.8%	187 63.6%	547 62.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	118 40.4%	110 38.2%	115 39.1%	343 39.2%
Not Hispanic or Latino	174 59.6%	178 61.8%	179 60.9%	531 60.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.3%	0 0%	1 0.1%
Asian	4 1.4%	6 2.1%	5 1.7%	15 1.7%
Native Hawaiian or Other Pacific Islander	1 0.3%	0 0%	2 0.7%	3 0.3%
Black or African American	109 37.3%	116 40.3%	91 31%	316 36.2%
White	177 60.6%	160 55.6%	193 65.6%	530 60.6%
More than one race	1 0.3%	5 1.7%	3 1%	9 1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts
Description	For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e., the lines around the nostrils and under the nostrils) and all mucus membranes.
Time Frame	Mean percent change from baseline to Week 12

Outcome Measure Data

Analysis Population Description

Mean percent change from baseline to Week 12 in Per Protocol Population

Arm/Group Title	Test	Reference	Vehicle
Arm/Group Description	Tazarotene 0.1% foam (Actavis LLC)	Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Placebo foam (Actavis LLC)
Measure Participants	187	185	195
Mean (Standard Deviation) [Percent change in inflammatory lesions]	-48.25 (26.743)	-52.72 (22.792)	-45.03 (24.092)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Reference
	Comments
	Type of Statistical Test	Equivalence
	Comments	Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 90%; 0.86 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval [0.80, 1.25] for the PP population.

2. Primary Outcome

Title	Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts
Description	Estimates of mean percent change from baseline for non-inflammatory lesions for the Test and Reference treatment.
Time Frame	Mean percent change from baseline to Week 12

Outcome Measure Data

Analysis Population Description

Percent change in the non-inflammatory lesions in Per Protocol Population.

Arm/Group Title	Test	Reference	Vehicle Foam
Arm/Group Description	Tazarotene 0.1% foam (Actavis LLC)	Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Placebo Foam (Actavis LLC)
Measure Participants	187	185	195
Mean (Standard Deviation) [percent change in noninflammatory lesion]	-41.98 (21.125)	-44.51 (20.062)	-37.42 (24.126)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Reference
	Comments
	Type of Statistical Test	Equivalence
	Comments	Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 90%; 0.89 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval [0.80, 1.25] for the PP population.

3. Secondary Outcome

Title	The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment
Time Frame	IGA score at Week 12 compared to baseline

Outcome Measure Data

Analysis Population Description

Treatment success based on IGA score at Week 12 in PP population

Arm/Group Title	Test	Reference	Vehicle
Arm/Group Description	Tazarotene 0.1% foam (Actavis LLC)	Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle foam of the test product (Actavis LLC)
Measure Participants	252	247	259
Success	103 35.3%	119 41.3%	88 29.9%
Failure	149 51%	128 44.4%	171 58.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Reference
	Comments	Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.
	Type of Statistical Test	Equivalence
	Comments	Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval [-0.20, +0.20] for PP population.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.073
	Confidence Interval	(2-Sided) 90%; -0.150 to 0.004
	Parameter Dispersion	Type: Value:
	Estimation Comments	Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval [-0.20, +0.20] for the PP population.

Adverse Events

Time Frame	Adverse event data were collected over approximately 13 weeks.
Arm/Group Title	Test		Reference		Vehicle
Arm/Group Description	Tazarotene 0.1% foam (Actavis LLC)		Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)		Vehicle foam of the test product (Actavis LLC)
All Cause Mortality
	Test		Reference		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/292 (0%)		0/288 (0%)		0/294 (0%)
Serious Adverse Events
	Test		Reference		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/292 (0%)		0/288 (0%)		0/294 (0%)
Other (Not Including Serious) Adverse Events
	Test		Reference		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/292 (14%)		55/288 (19.1%)		43/294 (14.6%)
Eye disorders
Eye Pain	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Eye Pruritis	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Eye swelling	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Gastrointestinal disorders
Abdominal pain	1/292 (0.3%)		1/288 (0.3%)		0/294 (0%)
Abdominal pain upper	1/292 (0.3%)		2/288 (0.7%)		1/294 (0.3%)
Diarrhoea	2/292 (0.7%)		2/288 (0.7%)		2/294 (0.7%)
Dry mouth	1/292 (0.3%)		0/288 (0%)		0/294 (0%)
Lip swelling	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Nausea	0/292 (0%)		3/288 (1%)		0/294 (0%)
Oral pain	0/292 (0%)		2/288 (0.7%)		0/294 (0%)
Toothache	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
General disorders
Application site reaction	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Chest pain	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Cyst	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Influenza like illness	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Pyrexia	1/292 (0.3%)		1/288 (0.3%)		1/294 (0.3%)
Immune system disorders
Food allergy	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Infections and infestations
Influenza	4/292 (1.4%)		5/288 (1.7%)		5/294 (1.7%)
Localized infection	1/292 (0.3%)		0/288 (0%)		0/294 (0%)
Nasopharyngitis	7/292 (2.4%)		5/288 (1.7%)		9/294 (3.1%)
Rhinitis	1/292 (0.3%)		0/288 (0%)		0/294 (0%)
Sinusitis	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Upper respiratory tract infection	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Injury, poisoning and procedural complications
Arthropod bite	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Ligament sprain	0/292 (0%)		1/288 (0.3%)		1/294 (0.3%)
Thermal burn	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Investigations
Heart rate increased	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/292 (0.3%)		0/288 (0%)		0/294 (0%)
Back pain	2/292 (0.7%)		1/288 (0.3%)		0/294 (0%)
Muscle spasms	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Neck pain	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Nervous system disorders
Burning sensation	1/292 (0.3%)		1/288 (0.3%)		1/294 (0.3%)
Headache	12/292 (4.1%)		17/288 (5.9%)		20/294 (6.8%)
Migraine	0/292 (0%)		1/288 (0.3%)		1/294 (0.3%)
Sinus headache	0/292 (0%)		1/288 (0.3%)		1/294 (0.3%)
Tension headache	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Psychiatric disorders
Anxiety	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Depression	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Sleep disorder	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Reproductive system and breast disorders
Dysmenorrhoea	7/292 (2.4%)		3/288 (1%)		5/294 (1.7%)
Ovarian cyst	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/292 (0%)		1/288 (0.3%)		1/294 (0.3%)
Nasal congestion	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Oropharyngeal pain	1/292 (0.3%)		1/288 (0.3%)		2/294 (0.7%)
Rhinorrhoea	1/292 (0.3%)		1/288 (0.3%)		0/294 (0%)
Sneezing	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Acne	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Skin and subcutaneous tissue disorders
Dry skin	1/292 (0.3%)		2/288 (0.7%)		0/294 (0%)
Erythema	1/292 (0.3%)		2/288 (0.7%)		1/294 (0.3%)
Hyperhidrosis	0/292 (0%)		1/288 (0.3%)		0/294 (0%)
Pruritus	1/292 (0.3%)		2/288 (0.7%)		1/294 (0.3%)
Rash	1/292 (0.3%)		2/288 (0.7%)		0/294 (0%)
Rash erythematous	0/292 (0%)		0/288 (0%)		1/294 (0.3%)
Skin exfoliation	2/292 (0.7%)		0/288 (0%)		0/294 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed