Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Study Details
Study Description
Brief Summary
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence study with clinical endpoint, at multiple study sites, designed to establish bioequivalence of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2% and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.
The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Onexton gel Clindamycin 1.2% and benzoyl peroxide 3.75% topical gel Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily |
Drug: Onexton
Topical gel for treating acne
Other Names:
|
| Experimental: Clindamycin/benzoyl peroxide gel Generic clindamycin 1.2% and benzoyl peroxide 3.75% topical gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily |
Drug: Clindamycin/benzoyl peroxide gel
Generic Clindamycin/benzoyl peroxide gel for treating acne
Other Names:
|
| Placebo Comparator: Placebo A vehicle gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily |
Drug: Placebo
Vehicle gel used as a placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts [12 weeks]
Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population.
- Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts [12 weeks]
One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population.
Secondary Outcome Measures
- Number of Subjects With Treatment Success at Week 12 [12 weeks]
The secondary efficacy endpoint was the IGA score, expressed in terms of proportion of subjects with treatment success or failure at Week 12, where "success" was defined as an IGA score that was at least 2 grades less than the baseline assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
-
On the face, ≥25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Counts of nodules and cysts should be reported separately and not included in the inflammatory or non-inflammatory lesion counts. Lesions involving the eyes and scalp should be excluded from the count. (Subjects may have acne lesions on other areas of the body (e.g., on the back)).
-
Subjects must have Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4.
-
Willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period. Subjects may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g. benzoyl peroxide, salicylic acid).
-
Subjects who are 18 years of age or older must have provided Institutional Review Board (IRB) approved written informed consent. Subjects who are at least 12 years of age and less than 18 years of age 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 Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
-
Male subjects and Female subjects of childbearing potential must use accepted methods of birth control or must agree to practice abstinence, from study start to 30 days after the last administration of study drug. All female subjects are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate), double barrier methods (e.g., condom and spermicide) or intrauterine device (IUD).
-
Female subjects of child bearing potential must have a negative urine pregnancy test at baseline.
-
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.
Exclusion Criteria:
-
History of hypersensitivity or allergy to clindamycin or benzoyl peroxide and/or any of the study medication ingredients or lincomycin or any other allowed product used during the study.
-
Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
-
Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Patient is allowed to shave the excessive facial hair at least a day before visiting the site for study assessments.
-
Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day.
-
Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
-
Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
-
Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris or 5) systemic anti-inflammatory agents.
-
Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti- inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.
-
Subjects who have acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
-
Female subjects who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 4 and 30 days post visit 4) will be excluded from study participation.
-
Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation.
-
Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
-
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 from study participation.
-
Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation.
-
Subjects who have facial sunburn will be excluded from study participation
-
Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by their medical history will be excluded from study participation.
-
History or presence of significant smoking (more than 10 cigarettes or any other form of tobacco smoking/day or consumption of tobacco products).
-
Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50 beats/minute or more than 100 beats/minute.
-
Subjects who have participated in an investigational drug study (i.e., subjects have been treated with an investigational drug) within 1 month 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.
-
Major illness, as per investigator's discretion, during 3 months before screening.
-
Subjects who have been previously enrolled in this study will be excluded from study participation.
-
Subjects who have had laser therapy and electrodesiccation to the facial area within 180 days prior to study entry will be excluded from participation.
-
Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation.
-
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 a baseline score of 3 (severe, marked/intense) as per the Application Site Reaction Scale (Section 5.2) will be excluded from participation.
-
Any employees or staff of the research site are excluded from study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alliance Dermatology | Phoenix | Arizona | United States | 85032 |
| 2 | Estudy | Chula Vista | California | United States | 91911 |
| 3 | Estudy | La Mesa | California | United States | 91942 |
| 4 | Tampa Bay Medical Research | Clearwater | Florida | United States | 33761 |
| 5 | AMB Research Center | Miami | Florida | United States | 33144 |
| 6 | Meridian Clinical Research | Savannah | Georgia | United States | 31406 |
| 7 | Heartland Research Assoc | Augusta | Kansas | United States | 67010 |
| 8 | Heartland Research Assoc | Wichita | Kansas | United States | 67207 |
| 9 | Sundance Clinical Research | Saint Louis | Missouri | United States | 63141 |
| 10 | Meridian Clinical Research | Norfolk | Nebraska | United States | 68701 |
| 11 | Meridian Clinical Research | Omaha | Nebraska | United States | 68134 |
| 12 | Dermatology Consulting Services | High Point | North Carolina | United States | 27262 |
| 13 | Sterling Research Group | Cincinnati | Ohio | United States | 45246 |
| 14 | Discover Research | Beaumont | Texas | United States | 77701 |
| 15 | DiscoverResearch Inc | Bryan | Texas | United States | 77802 |
| 16 | Reseacr Across America | Dallas | Texas | United States | 75234 |
| 17 | Clinical Research Assoc. of Tidewater | Norfolk | Virginia | United States | 23507 |
Sponsors and Collaborators
- Actavis Inc.
Investigators
- Study Director: Henry lau, PhD, Actavis Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WAT/CMBP/2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The populations for this study included the Safety Population, the Per-Protocol Population (PP), and the modified Intent-to-Treat (mITT) Population. |
| Arm/Group Title | Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel | Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel) | Vehicle Gel |
|---|---|---|---|
| Arm/Group Description | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. |
| Period Title: Overall Study | |||
| STARTED | 347 | 345 | 170 |
| Safety Population | 329 | 328 | 161 |
| mITT Population | 325 | 325 | 160 |
| PP Population | 253 | 255 | 122 |
| COMPLETED | 282 | 285 | 141 |
| NOT COMPLETED | 65 | 60 | 29 |
Baseline Characteristics
| Arm/Group Title | Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel | Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75) | Vehicle Gel | Total |
|---|---|---|---|---|
| Arm/Group Description | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | Total of all reporting groups |
| Overall Participants | 329 | 328 | 161 | 818 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
20.6
(7.56)
|
20.4
(7.04)
|
20.1
(6.92)
|
20.4
(7.23)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
204
62%
|
217
66.2%
|
105
65.2%
|
526
64.3%
|
| Male |
125
38%
|
111
33.8%
|
56
34.8%
|
292
35.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
76
23.1%
|
89
27.1%
|
45
28%
|
210
25.7%
|
| Not Hispanic or Latino |
253
76.9%
|
239
72.9%
|
116
72%
|
608
74.3%
|
| 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
1.2%
|
2
0.6%
|
1
0.6%
|
7
0.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
82
24.9%
|
86
26.2%
|
42
26.1%
|
210
25.7%
|
| White |
225
68.4%
|
224
68.3%
|
110
68.3%
|
559
68.3%
|
| More than one race |
18
5.5%
|
15
4.6%
|
8
5%
|
41
5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts |
|---|---|
| Description | Percent change from baseline to Week 12 (Day 84) in the inflammatory (papules and pustules) lesion count in PP Population. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Using the per-protocol population. |
| Arm/Group Title | Generic Clindamycin and Benzoyl Peroxide | Reference Onexton (Clindamycin and Benzoyl Peroxide) | Vehicle Gel |
|---|---|---|---|
| Arm/Group Description | Clindamycin 1.2% and Benzoyl Peroxide 3.75% gel (Actavis Laboratories SLC) | Onexton gel (Clindamycin 1.3% and Benzoyl Peroxide 3.75%) (Valeant Pharmaceuticals North America LLC) | Vehicle Gel: Placebo product |
| Measure Participants | 253 | 255 | 122 |
| Mean (Standard Deviation) [percentage of change] |
-63.81
(36.791)
|
-67.56
(28.405)
|
-53.78
(40.138)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Generic Clindamycin and Benzoyl Peroxide, Reference Onexton (Clindamycin and Benzoyl Peroxide) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Bioequivalence was established if the 90% CI for the difference was contained within the interval [0.80,1.25] for the PP population. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.95 | |
| Confidence Interval |
(2-Sided) 90% 0.88 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Generic Clindamycin and Benzoyl Peroxide |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Reference Onexton (Clindamycin and Benzoyl Peroxide) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Percent Change in the Non-Inflammatory (Open and Closed Comedomes) Lesion Counts |
|---|---|
| Description | One of the co-primary endpoints was the percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion counts in PP Population. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Using the per-protocol population. |
| Arm/Group Title | Generic Clindamycin and Benzoyl Peroxide | Reference Onexton (Clindamycin and Benzoyl Peroxide) | Vehicle Gel |
|---|---|---|---|
| Arm/Group Description | Clindamycin 1.2% and Benzoyl Peroxide 3.75% gel (Actavis Laboratories SLC) | Onexton gel (Clindamycin 1.3% and Benzoyl Peroxide 3.75%) (Valeant Pharmaceuticals North America LLC) | Vehicle Gel: Placebo product |
| Measure Participants | 253 | 255 | 122 |
| Mean (Standard Deviation) [percentage of change] |
-49.58
(40.747)
|
-49.50
(32.872)
|
-37.50
(40.261)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Generic Clindamycin and Benzoyl Peroxide, Reference Onexton (Clindamycin and Benzoyl Peroxide) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Bioequivalence was established if the 90% CI for the difference was contained within the interval [0.80, 1.25] for the PP population. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 1.00 | |
| Confidence Interval |
(2-Sided) 90% 0.90 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Generic Clindamycin and Benzoyl Peroxide |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Reference Onexton (Clindamycin and Benzoyl Peroxide) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Number of Subjects With Treatment Success at Week 12 |
|---|---|
| Description | The secondary efficacy endpoint was the IGA score, expressed in terms of proportion of subjects with treatment success or failure at Week 12, where "success" was defined as an IGA score that was at least 2 grades less than the baseline assessment. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Using the PP population. |
| Arm/Group Title | Generic Clindamycin and Benzoyl Peroxide | Reference Onexton (Clindamycin and Benzoyl Peroxide) | Vehicle Gel |
|---|---|---|---|
| Arm/Group Description | Clindamycin 1.2% and Benzoyl Peroxide 3.75% gel (Actavis Laboratories SLC) | Onexton gel (Clindamycin 1.3% and Benzoyl Peroxide 3.75%) (Valeant Pharmaceuticals North America LLC) | Vehicle of the test product (Actavis Laboratories SLC) |
| Measure Participants | 253 | 255 | 122 |
| Success |
54
16.4%
|
60
18.3%
|
13
8.1%
|
| Failure |
199
60.5%
|
195
59.5%
|
109
67.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Generic Clindamycin and Benzoyl Peroxide, Reference Onexton (Clindamycin and Benzoyl Peroxide) |
|---|---|---|
| Comments | Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20). | |
| Type of Statistical Test | Equivalence | |
| Comments | Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.022 | |
| Confidence Interval |
(2-Sided) 90% -0.087 to 0.043 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Equivalence was based on difference in the number of subjects with success. Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20). | |
Adverse Events
| Time Frame | Baseline to 12 Weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were collected from participants who were randomized and received the study drug. Safety population assessment | |||||
| Arm/Group Title | Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel | Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75) | Vehicle Gel | |||
| Arm/Group Description | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | Subjects applied one pea-sized amount of the investigational product to the entire face 1 time each day for a period of 84 days. | |||
All Cause Mortality |
||||||
| Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel | Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75) | Vehicle Gel | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/329 (0%) | 0/328 (0%) | 0/161 (0%) | |||
Serious Adverse Events |
||||||
| Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel | Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75) | Vehicle Gel | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/329 (1.2%) | 0/328 (0%) | 0/161 (0%) | |||
| Immune system disorders | ||||||
| Allergy to arthropod sting | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Cranio-cerebral injury | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Pregnancy, puerperium and perinatal conditions | ||||||
| Abortion spontaneous | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Psychiatric disorders | ||||||
| Bipolar disorder | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel | Reference Onexton (Clindamycin 1.2% and Benzoyl Peroxide 3.75) | Vehicle Gel | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 197/329 (59.9%) | 211/328 (64.3%) | 92/161 (57.1%) | |||
| Blood and lymphatic system disorders | ||||||
| Lymphadenopathy | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Cardiac disorders | ||||||
| Extrasystoles | 2/329 (0.6%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Sinus tachycardia | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Tachycardia | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Endocrine disorders | ||||||
| Goitre | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Eye disorders | ||||||
| Eye irritation | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Eye pain | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Eye swelling | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Aphthous stomatitis | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Dental caries | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Diarrhoea | 2/329 (0.6%) | 0/328 (0%) | 2/161 (1.2%) | |||
| Dry mouth | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Nausea | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Toothache | 2/329 (0.6%) | 0/328 (0%) | 0/161 (0%) | |||
| Vomiting | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| General disorders | ||||||
| Application site dryness | 11/329 (3.3%) | 9/328 (2.7%) | 2/161 (1.2%) | |||
| Application site erosion | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Application site erythema | 5/329 (1.5%) | 6/328 (1.8%) | 0/161 (0%) | |||
| Application site irritation | 0/329 (0%) | 3/328 (0.9%) | 3/161 (1.9%) | |||
| Application site oedema | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Application site pain | 4/329 (1.2%) | 4/328 (1.2%) | 1/161 (0.6%) | |||
| Application site pruritus | 4/329 (1.2%) | 5/328 (1.5%) | 3/161 (1.9%) | |||
| Chest pain | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Cyst | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Face oedema | 3/329 (0.9%) | 5/328 (1.5%) | 2/161 (1.2%) | |||
| Facial pain | 16/329 (4.9%) | 17/328 (5.2%) | 5/161 (3.1%) | |||
| Inflammation | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Local swelling | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Oedema | 2/329 (0.6%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Pain | 8/329 (2.4%) | 3/328 (0.9%) | 0/161 (0%) | |||
| Pyrexia | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Secretion discharge | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Hepatobiliary disorders | ||||||
| Non-alcoholic steatohepatitis | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Immune system disorders | ||||||
| Allergy to arthropod sting | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Infections and infestations | ||||||
| Body tinea | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Breast abscess | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Bronchitis | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Conjunctivitus | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Gastroenteritis viral | 2/329 (0.6%) | 0/328 (0%) | 0/161 (0%) | |||
| Herpes simplex | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Influenza | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Kidney infection | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Lower respiratory tract infection | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Nasopharyngitis | 1/329 (0.3%) | 1/328 (0.3%) | 1/161 (0.6%) | |||
| Oral herpes | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Otitis media | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Pharyngitis streptococcal | 1/329 (0.3%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Pneumonia | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Rash pustular | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Respiratory tract infection | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Sinusitus | 1/329 (0.3%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Skin infection | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Upper respiratory tract infection | 3/329 (0.9%) | 2/328 (0.6%) | 0/161 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Cartilage injury | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Cervical vertebral fracture | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Contusion | 1/329 (0.3%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Craniocerebral injury | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Joint dislocation | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Joint injury | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Ligament sprain | 1/329 (0.3%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Meniscus injury | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Muscle strain | 1/329 (0.3%) | 1/328 (0.3%) | 1/161 (0.6%) | |||
| Scar | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Skin abrasion | 1/329 (0.3%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Sunburn | 1/329 (0.3%) | 4/328 (1.2%) | 1/161 (0.6%) | |||
| Thermal burn | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Investigations | ||||||
| Blood pressure increased | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Heart rate increased | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Heart rate irregular | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Investigation | 2/329 (0.6%) | 2/328 (0.6%) | 2/161 (1.2%) | |||
| Investigation abnormal | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Weight increased | 1/329 (0.3%) | 2/328 (0.6%) | 0/161 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/329 (0%) | 2/328 (0.6%) | 0/161 (0%) | |||
| Flank pain | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Musculoskeletal pain | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Pain in extremity | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Nervous system disorders | ||||||
| Burning sensation | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Headache | 2/329 (0.6%) | 1/328 (0.3%) | 1/161 (0.6%) | |||
| Migraine | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Paraesthesia | 2/329 (0.6%) | 1/328 (0.3%) | 1/161 (0.6%) | |||
| Presyncope | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Sinus headache | 0/329 (0%) | 0/328 (0%) | 2/161 (1.2%) | |||
| Pregnancy, puerperium and perinatal conditions | ||||||
| Abortion spontaneous | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Psychiatric disorders | ||||||
| Bipolar disorder | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Depression | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Insomnia | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Renal and urinary disorders | ||||||
| Pollakiuria | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Dysmenorrhoea | 1/329 (0.3%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 0/329 (0%) | 1/328 (0.3%) | 1/161 (0.6%) | |||
| Nasal congestion | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Oropharyngeal pain | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Rhinitis allergic | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Rhinorrhoea | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Sinus congestion | 1/329 (0.3%) | 1/328 (0.3%) | 1/161 (0.6%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Acne | 9/329 (2.7%) | 9/328 (2.7%) | 10/161 (6.2%) | |||
| Blister | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Dermal cyst | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Dermatitis contact | 0/329 (0%) | 2/328 (0.6%) | 0/161 (0%) | |||
| Dry skin | 127/329 (38.6%) | 138/328 (42.1%) | 56/161 (34.8%) | |||
| Erythema | 55/329 (16.7%) | 58/328 (17.7%) | 31/161 (19.3%) | |||
| Hyperhidrosis | 1/329 (0.3%) | 0/328 (0%) | 0/161 (0%) | |||
| Pain of skin | 2/329 (0.6%) | 2/328 (0.6%) | 1/161 (0.6%) | |||
| Papule | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Pruritus | 59/329 (17.9%) | 70/328 (21.3%) | 31/161 (19.3%) | |||
| Rash | 2/329 (0.6%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Scab | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Seborrhoea | 0/329 (0%) | 2/328 (0.6%) | 2/161 (1.2%) | |||
| Skin burning sensation | 34/329 (10.3%) | 27/328 (8.2%) | 11/161 (6.8%) | |||
| Skin erosion | 12/329 (3.6%) | 22/328 (6.7%) | 8/161 (5%) | |||
| Skin exfoliation | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Skin irritation | 17/329 (5.2%) | 23/328 (7%) | 10/161 (6.2%) | |||
| Skin swelling | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Swelling face | 0/329 (0%) | 5/328 (1.5%) | 1/161 (0.6%) | |||
| Urticaria | 1/329 (0.3%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Surgical and medical procedures | ||||||
| Artificial crown procedure | 0/329 (0%) | 1/328 (0.3%) | 0/161 (0%) | |||
| Vascular disorders | ||||||
| Hot flush | 0/329 (0%) | 0/328 (0%) | 1/161 (0.6%) | |||
| Hypotension | 1/329 (0.3%) | 4/328 (1.2%) | 2/161 (1.2%) | |||
Limitations/Caveats
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.
Results Point of Contact
| Name/Title | Senior Director, CE Studies |
|---|---|
| Organization | Teva Pharmaceuticals USA, Inc. |
| Phone | 1-888-483-8279 |
| USMedInfo@tevapharm.com |
- WAT/CMBP/2015