Trial Outcomes & Findings for Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris (NCT NCT00829049)

Results Overview

Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

165 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2012-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Tazarotene Cream 0.1% 1 pea-size amount, QD x 16 weeks	Adapalene Gel 0.3% 1 pea-size amount, QD x 16 weeks
Overall Study STARTED	77	88
Overall Study COMPLETED	60	68
Overall Study NOT COMPLETED	17	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tazarotene Cream 0.1% n=77 Participants 1 pea-size amount, QD x 16 weeks	Adapalene Gel 0.3% n=88 Participants 1 pea-size amount, QD x 16 weeks	Total n=165 Participants Total of all reporting groups
Age Continuous	20.9 years FULL_RANGE 7.7 • n=93 Participants	20.8 years FULL_RANGE 7.6 • n=4 Participants	20.9 years FULL_RANGE 7.6 • n=27 Participants
Sex: Female, Male Female	48 Participants n=93 Participants	56 Participants n=4 Participants	104 Participants n=27 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	32 Participants n=4 Participants	61 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.

Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).

Outcome measures

Outcome measures
Measure	Tazarotene Cream 0.1% n=62 Participants 1 pea-size amount, QD x 16 weeks	Adapalene Gel 0.3% n=73 Participants 1 pea-size amount, QD x 16 weeks
Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12	-68.14 Percent Change Interval -96.23 to -2.99	-60.00 Percent Change Interval -100.0 to 42.86

SECONDARY outcome

Timeframe: Week 16

Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.

Percentage of patients with \>= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.

Outcome measures

Outcome measures
Measure	Tazarotene Cream 0.1% n=61 Participants 1 pea-size amount, QD x 16 weeks	Adapalene Gel 0.3% n=72 Participants 1 pea-size amount, QD x 16 weeks
Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16	77.0 Percentage of patients	66.7 Percentage of patients

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.

Percentage of patients with \>= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.

Outcome measures

Outcome measures
Measure	Tazarotene Cream 0.1% n=61 Participants 1 pea-size amount, QD x 16 weeks	Adapalene Gel 0.3% n=73 Participants 1 pea-size amount, QD x 16 weeks
Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12	50.8 Percentage of patients	32.9 Percentage of patients

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.

Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).

Outcome measures

Outcome measures
Measure	Tazarotene Cream 0.1% n=61 Participants 1 pea-size amount, QD x 16 weeks	Adapalene Gel 0.3% n=72 Participants 1 pea-size amount, QD x 16 weeks
Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16	-67.86 Percent Change Interval -100.0 to 32.0	-55.56 Percent Change Interval -100.0 to 38.46

Adverse Events

Tazarotene Cream 0.1%

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Adapalene Gel 0.3%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tazarotene Cream 0.1% n=72 participants at risk 1 pea-size amount, QD x 16 weeks	Adapalene Gel 0.3% n=85 participants at risk 1 pea-size amount, QD x 16 weeks
Infections and infestations Cold Symptoms	8.3% 6/72 The safety population was used to calculate the number of participants at risk for SAEs an AEs and is the total number of patients that were randomized AND treated.	5.9% 5/85 The safety population was used to calculate the number of participants at risk for SAEs an AEs and is the total number of patients that were randomized AND treated.
General disorders Burning	5.6% 4/72 The safety population was used to calculate the number of participants at risk for SAEs an AEs and is the total number of patients that were randomized AND treated.	4.7% 4/85 The safety population was used to calculate the number of participants at risk for SAEs an AEs and is the total number of patients that were randomized AND treated.

Additional Information

Vice President, Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER