Trial Outcomes & Findings for A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris (NCT NCT02267746)

Last Updated: 2020-06-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

893 participants

Primary outcome timeframe

Mean percent change from baseline to Week 12

Results posted on

2020-06-12

Participant Flow

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

Participant milestones

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

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Tazarotene 0.1% foam (Actavis LLC)	Reference Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle Vehicle foam of the test product (Actavis LLC)
Overall Study Adverse Event	0	2	1
Overall Study Protocol Violation	1	2	1
Overall Study Lack of Efficacy	11	11	15
Overall Study Miscellaneous	1	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test n=292 Participants Tazarotene 0.1% foam (Actavis LLC)	Reference n=288 Participants Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle n=294 Participants Vehicle foam of the test product (Actavis LLC)	Total n=874 Participants Total of all reporting groups
Age, Continuous	21.5 years STANDARD_DEVIATION 7.76 • n=5 Participants	21.1 years STANDARD_DEVIATION 7.26 • n=7 Participants	21.0 years STANDARD_DEVIATION 7.03 • n=5 Participants	21.2 years STANDARD_DEVIATION 7.35 • n=4 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	107 Participants n=7 Participants	107 Participants n=5 Participants	327 Participants n=4 Participants
Sex: Female, Male Male	179 Participants n=5 Participants	181 Participants n=7 Participants	187 Participants n=5 Participants	547 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	118 Participants n=5 Participants	110 Participants n=7 Participants	115 Participants n=5 Participants	343 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	174 Participants n=5 Participants	178 Participants n=7 Participants	179 Participants n=5 Participants	531 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	109 Participants n=5 Participants	116 Participants n=7 Participants	91 Participants n=5 Participants	316 Participants n=4 Participants
Race (NIH/OMB) White	177 Participants n=5 Participants	160 Participants n=7 Participants	193 Participants n=5 Participants	530 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Mean percent change from baseline to Week 12

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

Outcome measures

Outcome measures
Measure	Test n=187 Participants Tazarotene 0.1% foam (Actavis LLC)	Reference n=185 Participants Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle n=195 Participants Placebo foam (Actavis LLC)
Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts	-48.25 Percent change in inflammatory lesions Standard Deviation 26.743	-52.72 Percent change in inflammatory lesions Standard Deviation 22.792	-45.03 Percent change in inflammatory lesions Standard Deviation 24.092

PRIMARY outcome

Timeframe: Mean percent change from baseline to Week 12

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

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

Outcome measures

Outcome measures
Measure	Test n=187 Participants Tazarotene 0.1% foam (Actavis LLC)	Reference n=185 Participants Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle n=195 Participants Placebo foam (Actavis LLC)
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts	-41.98 percent change in noninflammatory lesion Standard Deviation 21.125	-44.51 percent change in noninflammatory lesion Standard Deviation 20.062	-37.42 percent change in noninflammatory lesion Standard Deviation 24.126

SECONDARY outcome

Timeframe: IGA score at Week 12 compared to baseline

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

Outcome measures

Outcome measures
Measure	Test n=252 Participants Tazarotene 0.1% foam (Actavis LLC)	Reference n=247 Participants Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle n=259 Participants Placebo foam (Actavis LLC)
The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment Failure	149 Participants	128 Participants	171 Participants
The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment Success	103 Participants	119 Participants	88 Participants

Adverse Events

Test

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Reference

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, CE Studies

Teva Pharmaceuticals USA, Inc.

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER

Measure	Test n=292 participants at risk Tazarotene 0.1% foam (Actavis LLC)	Reference n=288 participants at risk Reference listed drug: Fabior™ 0.1% (tazarotene) foam (Stiefel Laboratories LLC)	Vehicle n=294 participants at risk Vehicle foam of the test product (Actavis LLC)
Eye disorders Eye Pain	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Eye disorders Eye Pruritis	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Eye disorders Eye swelling	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Abdominal pain	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Abdominal pain upper	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.69% 2/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Diarrhoea	0.68% 2/292 • Adverse event data were collected over approximately 13 weeks.	0.69% 2/288 • Adverse event data were collected over approximately 13 weeks.	0.68% 2/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Dry mouth	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Lip swelling	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Nausea	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	1.0% 3/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Oral pain	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.69% 2/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Gastrointestinal disorders Toothache	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
General disorders Application site reaction	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
General disorders Chest pain	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
General disorders Cyst	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
General disorders Influenza like illness	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
General disorders Pyrexia	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Immune system disorders Food allergy	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Infections and infestations Influenza	1.4% 4/292 • Adverse event data were collected over approximately 13 weeks.	1.7% 5/288 • Adverse event data were collected over approximately 13 weeks.	1.7% 5/294 • Adverse event data were collected over approximately 13 weeks.
Infections and infestations Localized infection	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Infections and infestations Nasopharyngitis	2.4% 7/292 • Adverse event data were collected over approximately 13 weeks.	1.7% 5/288 • Adverse event data were collected over approximately 13 weeks.	3.1% 9/294 • Adverse event data were collected over approximately 13 weeks.
Infections and infestations Rhinitis	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Infections and infestations Sinusitis	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Infections and infestations Upper respiratory tract infection	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Investigations Heart rate increased	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.68% 2/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Nervous system disorders Burning sensation	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Nervous system disorders Headache	4.1% 12/292 • Adverse event data were collected over approximately 13 weeks.	5.9% 17/288 • Adverse event data were collected over approximately 13 weeks.	6.8% 20/294 • Adverse event data were collected over approximately 13 weeks.
Nervous system disorders Migraine	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Nervous system disorders Sinus headache	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Nervous system disorders Tension headache	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Psychiatric disorders Anxiety	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Psychiatric disorders Depression	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Psychiatric disorders Sleep disorder	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Reproductive system and breast disorders Dysmenorrhoea	2.4% 7/292 • Adverse event data were collected over approximately 13 weeks.	1.0% 3/288 • Adverse event data were collected over approximately 13 weeks.	1.7% 5/294 • Adverse event data were collected over approximately 13 weeks.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.68% 2/294 • Adverse event data were collected over approximately 13 weeks.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Respiratory, thoracic and mediastinal disorders Acne	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Skin and subcutaneous tissue disorders Dry skin	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.69% 2/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Skin and subcutaneous tissue disorders Erythema	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.69% 2/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.35% 1/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Skin and subcutaneous tissue disorders Pruritus	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.69% 2/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Skin and subcutaneous tissue disorders Rash	0.34% 1/292 • Adverse event data were collected over approximately 13 weeks.	0.69% 2/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.34% 1/294 • Adverse event data were collected over approximately 13 weeks.
Skin and subcutaneous tissue disorders Skin exfoliation	0.68% 2/292 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/288 • Adverse event data were collected over approximately 13 weeks.	0.00% 0/294 • Adverse event data were collected over approximately 13 weeks.