Brief Summary

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

257

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2008

Shorter than P25 for phase_2

Geographic Reach

1 country

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

First Submitted

Initial submission to the registry

January 25, 2008

Completed

7 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed

10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

April 19, 2011

Completed

Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

9 months

First QC Date

January 25, 2008

Results QC Date

February 14, 2011

Last Update Submit

April 15, 2013

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
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.
Week 12
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
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.
Baseline to Week 12

Secondary Outcomes (2)

Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
Baseline to Week 12
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
Baseline to Week 12

Study Arms (4)

Doxycyline 0.6 mg/kg/day

EXPERIMENTAL

Doxycycline dosed at 40 mg/day to subjects of appropriate weights

Drug: Doxycycline 0.6 mg/kg/day

Doxycycline 1.2 mg/kg/day

EXPERIMENTAL

Doxycycline dosed at 80 mg/day to subjects of appropriate weights

Drug: Doxycycline 1.2 mg/kg/day

Doxycycline 2.4 mg/kg/day

EXPERIMENTAL

Doxycycline dosed at 160 mg/day to subjects of appropriate weights

Drug: Doxycycline 2.4 mg/kg/day

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Doxycycline 0.6 mg/kg/dayDRUG

doxycycline 40 mg/day, oral, 12 weeks

Doxycyline 0.6 mg/kg/day

Doxycycline 1.2 mg/kg/dayDRUG

doxycycline 80 mg/day, 12 weeks

Doxycycline 1.2 mg/kg/day

Doxycycline 2.4 mg/kg/dayDRUG

doxycycline 160 mg/day, 12 weeks

Doxycycline 2.4 mg/kg/day

PlaceboDRUG

Placebo, 12 weeks

Placebo

Eligibility Criteria

Age12 Years - 45 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Must be between 12 and 45 years of age.
Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

You may not qualify if:

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.

Contact the study team to confirm eligibility.