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

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00829049
• Collaborator: (none)
• Enrollment: 165
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 13.7

Study Details

Study Description

Brief Summary

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Tazarotene Cream 0.1%; Drug: Adapalene	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tazarotene Cream 0.1% 1 pea-size amount, QD x 16 weeks	Drug: Tazarotene Cream 0.1%; 1 pea-size amount, QD x 16 weeks; Other Names: TAZORAC® Cream 0.1%
Active Comparator: Adapalene Gel 0.3% 1 pea-size amount, QD x 16 weeks	Drug: Adapalene; 1 pea-size amount, QD x 16 weeks; Other Names: Differin® Gel 0.3%

Outcome Measures

Primary Outcome Measures

1. Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [Baseline, Week 12]

   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).

Secondary Outcome Measures

1. Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 [Week 16]

   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.

2. Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 [Week 12]

   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.

3. Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 [Baseline, Week 16]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).

• Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Exclusion Criteria:

• Non-compliance with washout period

• Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris

• Allergy or sensitivity to any component of the test medications

• Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fremont	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00829049
• Other Study ID Numbers: MA-TAZ0702
• First Posted: Jan 26, 2009
• Last Update Posted: Sep 12, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Acne Vulgaris; Adapalene; Tazarotene

Study Results

Participant Flow

Arm/Group Title	Tazarotene Cream 0.1%	Adapalene Gel 0.3%
Arm/Group Description	1 pea-size amount, QD x 16 weeks	1 pea-size amount, QD x 16 weeks
Period Title: Overall Study
STARTED	77	88
COMPLETED	60	68
NOT COMPLETED	17	20

Baseline Characteristics

Arm/Group Title	Tazarotene Cream 0.1%	Adapalene Gel 0.3%	Total
Arm/Group Description	1 pea-size amount, QD x 16 weeks	1 pea-size amount, QD x 16 weeks	Total of all reporting groups
Overall Participants	77	88	165
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	20.9 (7.7)	20.8 (7.6)	20.9 (7.6)
Sex: Female, Male (Count of Participants)
Female	48 62.3%	56 63.6%	104 63%
Male	29 37.7%	32 36.4%	61 37%

Outcome Measures

1. Primary Outcome

Title	Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Description	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).
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tazarotene Cream 0.1%	Adapalene Gel 0.3%
Arm/Group Description	1 pea-size amount, QD x 16 weeks	1 pea-size amount, QD x 16 weeks
Measure Participants	62	73
Median (Full Range) [Percent Change]	-68.14	-60.00

2. Secondary Outcome

Title	Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16
Description	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.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tazarotene Cream 0.1%	Adapalene Gel 0.3%
Arm/Group Description	1 pea-size amount, QD x 16 weeks	1 pea-size amount, QD x 16 weeks
Measure Participants	61	72
Number [Percentage of patients]	77.0	66.7

3. Secondary Outcome

Title	Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tazarotene Cream 0.1%	Adapalene Gel 0.3%
Arm/Group Description	1 pea-size amount, QD x 16 weeks	1 pea-size amount, QD x 16 weeks
Measure Participants	61	73
Number [Percentage of patients]	50.8	32.9

4. Secondary Outcome

Title	Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16
Description	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).
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tazarotene Cream 0.1%	Adapalene Gel 0.3%
Arm/Group Description	1 pea-size amount, QD x 16 weeks	1 pea-size amount, QD x 16 weeks
Measure Participants	61	72
Median (Full Range) [Percent Change]	-67.86	-55.56

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Tazarotene Cream 0.1%		Adapalene Gel 0.3%
Arm/Group Description	1 pea-size amount, QD x 16 weeks		1 pea-size amount, QD x 16 weeks
All Cause Mortality
	Tazarotene Cream 0.1%		Adapalene Gel 0.3%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tazarotene Cream 0.1%		Adapalene Gel 0.3%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/85 (0%)
Other (Not Including Serious) Adverse Events
	Tazarotene Cream 0.1%		Adapalene Gel 0.3%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/72 (13.9%)		9/85 (10.6%)
General disorders
Burning	4/72 (5.6%)		4/85 (4.7%)
Infections and infestations
Cold Symptoms	6/72 (8.3%)		5/85 (5.9%)

Limitations/Caveats

Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.

More Information

Certain Agreements

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

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