Treatment of Moderate to Severe Facial Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT00612573|
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Doxycycline 0.6 mg/kg/day Drug: Doxycycline 1.2 mg/kg/day Drug: Doxycycline 2.4 mg/kg/day Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||257 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Study Randomized, Double-blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
Experimental: Doxycyline 0.6 mg/kg/day
Doxycycline dosed at 40 mg/day to subjects of appropriate weights
Drug: Doxycycline 0.6 mg/kg/day
doxycycline 40 mg/day, oral, 12 weeks
Experimental: Doxycycline 1.2 mg/kg/day
Doxycycline dosed at 80 mg/day to subjects of appropriate weights
Drug: Doxycycline 1.2 mg/kg/day
doxycycline 80 mg/day, 12 weeks
Experimental: Doxycycline 2.4 mg/kg/day
Doxycycline dosed at 160 mg/day to subjects of appropriate weights
Drug: Doxycycline 2.4 mg/kg/day
doxycycline 160 mg/day, 12 weeks
|Placebo Comparator: Placebo||
Placebo, 12 weeks
- Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population [ Time Frame: Week 12 ]IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.
- Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population [ Time Frame: Baseline to Week 12 ]Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.
- Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]Noninflammatory Lesion Count includes open and closed comedones.
- Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]Total Lesion Count is the sum of inflammatory and noninflammatory lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612573
Show 23 Study Locations
|Study Director:||Angelo Secci, MD||Warner Chilcott|