Trial Outcomes & Findings for Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne (NCT NCT00713609)

Last Updated: 2017-03-06

Results Overview

The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts \[only post-Baseline\]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

591 participants

Primary outcome timeframe

Baseline and up to Week 12

Results posted on

2017-03-06

Participant Flow

In this multi-center, double-blind, vehicle controlled study, participants were assigned to one of the six treatment groups in a 2:2:2:2:2:1 ratio for 12 weeks.

Participants with facial acne vulgaris, 12 to 45 years of age were enrolled in this study. A total of 596 participants were randomized and 587 participants received study product.

Participant milestones

Participant milestones
Measure	Clindamycin Gel + Tazarotene Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Tazarotene Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Vehicle Cream Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide/Clindamycin + Tazarotene Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams \[g\] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face	Benzoyl Peroxide/Clindamycin + Vehicle Cream Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide Gel + Tazarotene Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Overall Study STARTED	108	106	55	106	105	107
Overall Study COMPLETED	99	87	47	85	90	92
Overall Study NOT COMPLETED	9	19	8	21	15	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Clindamycin Gel + Tazarotene Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Tazarotene Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Vehicle Cream Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide/Clindamycin + Tazarotene Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams \[g\] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face	Benzoyl Peroxide/Clindamycin + Vehicle Cream Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide Gel + Tazarotene Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Overall Study Adverse Event	2	3	1	2	0	2
Overall Study Lost to Follow-up	5	7	0	5	7	5
Overall Study Lack of Efficacy	0	1	0	1	3	0
Overall Study Non-Compliance with Study Treatment	0	1	0	1	1	2
Overall Study Withdrawal by Subject	1	5	7	6	1	5
Overall Study Protocol Violation	1	2	0	6	3	1

Baseline Characteristics

Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benzoyl Peroxide/Clindamycin + Tazarotene n=106 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams \[g\] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face	Benzoyl Peroxide/Clindamycin + Vehicle Cream n=105 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide Gel + Tazarotene n=107 Participants Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Clindamycin Gel + Tazarotene n=108 Participants Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Tazarotene n=106 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Vehicle Cream n=55 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Total n=587 Participants Total of all reporting groups
Age, Continuous	19.7 Years STANDARD_DEVIATION 6.6 • n=5 Participants	19.7 Years STANDARD_DEVIATION 6.9 • n=7 Participants	20.2 Years STANDARD_DEVIATION 7.3 • n=5 Participants	19.2 Years STANDARD_DEVIATION 6.2 • n=4 Participants	21.7 Years STANDARD_DEVIATION 8.4 • n=21 Participants	19.8 Years STANDARD_DEVIATION 6.6 • n=8 Participants	20.1 Years STANDARD_DEVIATION 7.1 • n=8 Participants
Gender Female	58 Participants n=5 Participants	56 Participants n=7 Participants	60 Participants n=5 Participants	60 Participants n=4 Participants	65 Participants n=21 Participants	35 Participants n=8 Participants	334 Participants n=8 Participants
Gender Male	48 Participants n=5 Participants	49 Participants n=7 Participants	47 Participants n=5 Participants	48 Participants n=4 Participants	41 Participants n=21 Participants	20 Participants n=8 Participants	253 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	14 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants	5 Participants n=8 Participants	47 Participants n=8 Participants
Race/Ethnicity, Customized Black	23 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants	15 Participants n=4 Participants	14 Participants n=21 Participants	8 Participants n=8 Participants	100 Participants n=8 Participants
Race/Ethnicity, Customized Multiracial	10 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	5 Participants n=8 Participants	51 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized White	63 Participants n=5 Participants	63 Participants n=7 Participants	68 Participants n=5 Participants	79 Participants n=4 Participants	74 Participants n=21 Participants	37 Participants n=8 Participants	384 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and up to Week 12

Population: Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.

Outcome measures

Outcome measures
Measure	Benzoyl Peroxide/Clindamycin + Tazarotene n=106 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams \[g\] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide/Clindamycin + Vehicle Cream n=105 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide Gel + Tazarotene n=107 Participants Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Clindamycin Gel + Tazarotene n=107 Participants Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Tazarotene n=106 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Vehicle Cream n=55 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 ILC, n=101, 103, 105, 105, 104, 52	-16.8 Lesion count Standard Deviation 14.35	-18.1 Lesion count Standard Deviation 14.45	-18.9 Lesion count Standard Deviation 12.84	-18.8 Lesion count Standard Deviation 11.49	-14.5 Lesion count Standard Deviation 12.76	-8.96 Lesion count Standard Deviation 12.63
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 NILC, n=101, 103, 105, 105, 104, 52	-33.0 Lesion count Standard Deviation 23.94	-24.9 Lesion count Standard Deviation 33.41	-37.1 Lesion count Standard Deviation 29.70	-37.5 Lesion count Standard Deviation 29.51	-33.0 Lesion count Standard Deviation 25.89	-18.9 Lesion count Standard Deviation 28.41
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 TLC, n=101, 103, 105, 105, 104, 52	-49.8 Lesion count Standard Deviation 31.78	-43.0 Lesion count Standard Deviation 42.24	-56.0 Lesion count Standard Deviation 34.99	-56.3 Lesion count Standard Deviation 35.42	-47.6 Lesion count Standard Deviation 33.32	-27.8 Lesion count Standard Deviation 35.06

PRIMARY outcome

Timeframe: Baseline and up to Week 12

Population: ITT Analysis Set

An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Benzoyl Peroxide/Clindamycin + Tazarotene n=106 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams \[g\] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide/Clindamycin + Vehicle Cream n=105 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide Gel + Tazarotene n=107 Participants Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Clindamycin Gel + Tazarotene n=108 Participants Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Tazarotene n=106 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Vehicle Cream n=55 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	22 Percentage of participants	22 Percentage of participants	31 Percentage of participants	36 Percentage of participants	20 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and up to Week 12

Population: ITT Analysis Set

The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Benzoyl Peroxide/Clindamycin + Tazarotene n=106 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams \[g\] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide/Clindamycin + Vehicle Cream n=105 Participants Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Benzoyl Peroxide Gel + Tazarotene n=107 Participants Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Clindamycin Gel + Tazarotene n=108 Participants Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Tazarotene n=106 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.	Vehicle Gel + Vehicle Cream n=55 Participants Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) NILC, n=101, 103, 105, 105, 104, 52	-58.0 Percent change Standard Deviation 29.97	-39.2 Percent change Standard Deviation 51.29	-60.6 Percent change Standard Deviation 35.00	-61.2 Percent change Standard Deviation 31.60	-53.1 Percent change Standard Deviation 30.56	-29.5 Percent change Standard Deviation 44.05
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) ILC, n=101, 103, 105, 105, 104, 52	-58.3 Percent change Standard Deviation 45.57	-62.4 Percent change Standard Deviation 39.33	-62.4 Percent change Standard Deviation 34.83	-65.7 Percent change Standard Deviation 33.38	-49.0 Percent change Standard Deviation 40.90	-33.5 Percent change Standard Deviation 41.10
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) TLC, n=101, 103, 105, 105, 104, 52	-59.1 Percent change Standard Deviation 29.96	-47.9 Percent change Standard Deviation 38.89	-62.0 Percent change Standard Deviation 29.42	-63.4 Percent change Standard Deviation 28.75	-51.8 Percent change Standard Deviation 29.18	-31.5 Percent change Standard Deviation 37.59

SECONDARY outcome

Timeframe: Week 12

Population: ITT Analysis Set