Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

• Sponsor: Warner Chilcott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00635609
• Collaborator: (none)
• Enrollment: 93
• Locations: 4
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 23.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Doxycycline hyclate (Doryx); Drug: Doxycycline hyclate	Phase 4

Detailed Description

Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Open-label Study to Evaluate the Efficacy and Safety of Doryx Tablets Compared to Doxycycline Hyclate in the Treatment of Acne Vulgaris.
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Doxycycline hyclate (Doryx)	Drug: Doxycycline hyclate (Doryx); 150mg/day, oral, delayed release tablets; Other Names: Doryx
Active Comparator: Doxycycline hyclate	Drug: Doxycycline hyclate; 100 mg/day, oral, tablets, immediate release

Outcome Measures

Primary Outcome Measures

1. Successful Outcome According to Investigator's Global Assessment (IGA) [baseline and 12 weeks]

   The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.

2. Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks [baseline and 12 weeks]

   Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.

Secondary Outcome Measures

1. Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks [baseline and 12 weeks]

   Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Must be 12 years of age or older.

• Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.

Exclusion Criteria:

• Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.

• Has a history of pseudomembranous colitis or antibiotic-associated colitis.

• Has a history of hepatitis or liver damage or renal impairment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warner Chilcott Investigational Site	Vista	California	United States	92083
2	Warner Chilcott Investigational Site	Miami	Florida	United States	33175
3	Warner Chilcott Investigational Site	Louisville	Kentucky	United States	40217
4	Warner Chilcott Investigational Site	Rochester	New York	United States	14623

Sponsors and Collaborators

• Warner Chilcott

Investigators

• Study Director: Angelo Secci, MD, Warner Chilcott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT00635609
• Other Study ID Numbers: PR-08607
• First Posted: Mar 14, 2008
• Last Update Posted: Apr 20, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Acne Vulgaris; Doxycycline

Study Results

Participant Flow

Arm/Group Title	Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline Hyclate Immediate-release Tablets
Arm/Group Description	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily	Doxycycline hyclate immediate-release tablets, 100 mg once daily
Period Title: Overall Study
STARTED	48	45
COMPLETED	41	42
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline Hyclate Immediate-release Tablets	Total
Arm/Group Description	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily	Doxycycline hyclate immediate-release tablets, 100 mg once daily	Total of all reporting groups
Overall Participants	48	45	93
Age (Count of Participants)
<=18 years	28 58.3%	21 46.7%	49 52.7%
Between 18 and 65 years	20 41.7%	24 53.3%	44 47.3%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.3 (5.8)	20.9 (7.9)	20.1 (6.9)
Sex: Female, Male (Count of Participants)
Female	17 35.4%	16 35.6%	33 35.5%
Male	31 64.6%	29 64.4%	60 64.5%
Region of Enrollment (participants) [Number]
United States	48 100%	45 100%	93 100%
Ethnic Origin (participants) [Number]
Hispanic	27 56.3%	26 57.8%	53 57%
Not of Hispanic origin	21 43.8%	19 42.2%	40 43%
Race (participants) [Number]
Asian or Pacific Islander	0 0%	1 2.2%	1 1.1%
Black	3 6.3%	5 11.1%	8 8.6%
Caucasian	22 45.8%	18 40%	40 43%
Other	23 47.9%	21 46.7%	44 47.3%

Outcome Measures

1. Primary Outcome

Title	Successful Outcome According to Investigator's Global Assessment (IGA)
Description	The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline Hyclate Immediate-release Tablets
Arm/Group Description	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily	Doxycycline hyclate immediate-release tablets, 100 mg once daily
Measure Participants	48	45
Number [participants]	18 37.5%	19 42.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Doxycycline Hyclate (Doryx) Delayed-release Tablets, Doxycycline Hyclate Immediate-release Tablets
	Comments	Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.765
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified on investigational site.

2. Secondary Outcome

Title	Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks
Description	Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline Hyclate Immediate-release Tablets
Arm/Group Description	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily	Doxycycline hyclate immediate-release tablets, 100 mg once daily
Measure Participants	48	45
Mean (Standard Deviation) [Acne lesion count]	23.2 (19.3)	27.6 (20.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Doxycycline Hyclate (Doryx) Delayed-release Tablets, Doxycycline Hyclate Immediate-release Tablets
	Comments	Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.290
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified on investigational site.

3. Primary Outcome

Title	Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks
Description	Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

intention to treat (ITT)

Arm/Group Title	Doxycycline Hyclate (Doryx) Delayed-release Tablets	Doxycycline Hyclate Immediate-release Tablets
Arm/Group Description	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily	Doxycycline hyclate immediate-release tablets, 100 mg once daily
Measure Participants	48	45
Mean (Standard Deviation) [acne lesion count]	21.8 (13.8)	26.6 (12.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Doxycycline Hyclate (Doryx) Delayed-release Tablets, Doxycycline Hyclate Immediate-release Tablets
	Comments	Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified on investigational site

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Doxycycline Hyclate (Doryx) Delayed-release Tablets		Doxycycline Hyclate Immediate-release Tablets
Arm/Group Description	Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily		Doxycycline hyclate immediate-release tablets, 100 mg once daily
All Cause Mortality
	Doxycycline Hyclate (Doryx) Delayed-release Tablets		Doxycycline Hyclate Immediate-release Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Doxycycline Hyclate (Doryx) Delayed-release Tablets		Doxycycline Hyclate Immediate-release Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/48 (2.1%)		1/45 (2.2%)
Hepatobiliary disorders
Acute cholecystitis	1/48 (2.1%)	1	0/45 (0%)	0
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy	0/48 (0%)	0	1/45 (2.2%)	1
Other (Not Including Serious) Adverse Events
	Doxycycline Hyclate (Doryx) Delayed-release Tablets		Doxycycline Hyclate Immediate-release Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/48 (20.8%)		11/45 (24.4%)
Gastrointestinal disorders
Nausea	0/48 (0%)	0	4/45 (8.9%)	4
Injury, poisoning and procedural complications
Sunburn	3/48 (6.3%)	3	1/45 (2.2%)	1
Nervous system disorders
Headache	7/48 (14.6%)	7	3/45 (6.7%)	3
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis	0/48 (0%)	0	3/45 (6.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.