Acne VulgarisPhase 2NCT00612573

Treatment of Moderate to Severe Facial Acne Vulgaris

A Phase 2 study testing Doxycycline 0.6 mg/kg/day, Doxycycline 1.2 mg/kg/day and Doxycycline 2.4 mg/kg/day in people with Acne Vulgaris, run by Warner Chilcott at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 12 to 45 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Doxycycline 0.6 mg/kg/day, Doxycycline 1.2 mg/kg/day and Doxycycline 2.4 mg/kg/day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 257 participants
Where: 23 sitesUnited States
Study dates: Feb 2008to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Warner Chilcott Investigational Site
Albuquerque, New Mexico, 87106-5239
Warner Chilcott Investigational Site
Austin, Texas, 78759
Warner Chilcott Investigational Site
Broomall, Pennsylvania, 19008
Warner Chilcott Investigational Site
Cincinnati, Ohio, 45219
Warner Chilcott Investigational Site
Clinton Township, Michigan, 48038
Warner Chilcott Investigational Site
College Station, Texas, 77845
Warner Chilcott Investigational Site
Dallas, Texas, 75246
Warner Chilcott Investigational Site
Denver, Colorado, 80210
Warner Chilcott Investigational Site
Encino, California, 91436
Warner Chilcott Investigational Site
Fort Washington, Pennsylvania, 19034
Warner Chilcott Investigational Site
Fremont, California, 94538
Warner Chilcott Investigational Site
Houston, Texas, 77056
Warner Chilcott Investigational Site
Los Angeles, California, 90045
Warner Chilcott Investigational Site
Louisville, Kentucky, 40217
Warner Chilcott Investigational Site
Miami, Florida, 33175
Warner Chilcott Investigational Site
Newnan, Georgia, 30263
Warner Chilcott Investigational Site
Portland, Oregon, 97210
Warner Chilcott Investigational Site
Rochester, New York, 14623
Warner Chilcott Investigational Site
Sacramento, California, 95816
Warner Chilcott Investigational Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Site
Snellville, Georgia, 30078
Warner Chilcott Investigational Site
Spokane, Washington, 99204
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

Conditions: Acne Vulgaris
Being tested: Doxycycline 0.6 mg/kg/day, Doxycycline 1.2 mg/kg/day, Doxycycline 2.4 mg/kg/day, Placebo
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Doxycycline 0.6 mg/kg/dayDrug
doxycycline 40 mg/day, oral, 12 weeks
Doxycycline 1.2 mg/kg/dayDrug
doxycycline 80 mg/day, 12 weeks
Doxycycline 2.4 mg/kg/dayDrug
doxycycline 160 mg/day, 12 weeks
PlaceboDrug
Placebo, 12 weeks

Study groups in NCT00612573
Study group	Role	What they receive
Doxycyline 0.6 mg/kg/day	Experimental	Doxycycline dosed at 40 mg/day to subjects of appropriate weights Receives: 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 Receives: 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 Receives: Drug: Doxycycline 2.4 mg/kg/day
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline to Week 12

Secondary outcomes (2)

Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population
Noninflammatory Lesion Count includes open and closed comedones.
Measured: Baseline to Week 12
Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population
Total Lesion Count is the sum of inflammatory and noninflammatory lesions.
Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Dec 2008

First posted11 Feb 2008 (estimated)
Study startFeb 2008
Primary completionNov 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 257 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00612573
Sponsor's protocol ID: PR-07907
Other IDs: WC2055
Status last verified: Apr 2013
First submitted: 25 Jan 2008
Last updated: 22 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00612573
Acronym / sponsor ID: PR-07907
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 257 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Nov 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 11 Feb 2008 (estimated)
Results: Posted 19 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Doxycyline 0.6 mg/kg/day	Experimental	Drug: Doxycycline 0.6 mg/kg/dayDoxycycline dosed at 40 mg/day to subjects of appropriate weights
Doxycycline 1.2 mg/kg/day	Experimental	Drug: Doxycycline 1.2 mg/kg/dayDoxycycline dosed at 80 mg/day to subjects of appropriate weights
Doxycycline 2.4 mg/kg/day	Experimental	Drug: Doxycycline 2.4 mg/kg/dayDoxycycline dosed at 160 mg/day to subjects of appropriate weights
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 12 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Doxycycline 0.6 mg/kg/daydoxycycline 40 mg/day, oral, 12 weeks	Drug	Doxycyline 0.6 mg/kg/day
Doxycycline 1.2 mg/kg/daydoxycycline 80 mg/day, 12 weeks	Drug	Doxycycline 1.2 mg/kg/day
Doxycycline 2.4 mg/kg/daydoxycycline 160 mg/day, 12 weeks	Drug	Doxycycline 2.4 mg/kg/day
PlaceboPlacebo, 12 weeks	Drug	Placebo

Primary outcome

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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 19 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Doxycycline 0.6 mg/kg/Day	64	52
Doxycycline 1.2 mg/kg/Day	65	51
Doxycycline 2.4 mg/kg/Day	61	52
Placebo Comparator	67	54

Primary outcome: Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population

Time frame: Week 12. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Doxycycline 0.6 mg/kg/Day n = 64	Doxycycline 1.2 mg/kg/Day n = 65	Doxycycline 2.4 mg/kg/Day n = 61	Placebo Comparator n = 67
Value	14.1 (6.6 to 25.0)	15.4 (7.6 to 26.5)	29.5 (18.5 to 42.6)	16.4 (8.5 to 27.5)

Doxycycline 0.6 mg/kg/Day vs Placebo Comparator: Mean Change from Baseline: -0.75 (95% CI -14.8 to 10.3), p = 0.779, Cochran-Mantel-Haenszel
Doxycycline 1.2 mg/kg/Day vs Placebo Comparator: Mean Change from Baseline: -0.69 (95% CI -13.7 to 11.7), p = 0.983, Cochran-Mantel-Haenszel
Doxycycline 2.4 mg/kg/Day vs Placebo Comparator: Mean Change from Baseline: -0.92 (95% CI -1.5 to 27.3), p = 0.087, Cochran-Mantel-Haenszel

Population analysed: ITT Population

Primary outcome: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Lesions

Measure	Doxycycline 0.6 mg/kg/Day n = 64	Doxycycline 1.2 mg/kg/Day n = 65	Doxycycline 2.4 mg/kg/Day n = 61	Placebo Comparator n = 67
Value	8.1 (13.2)	11.5 (12.1)	14.0 (19.7)	7.3 (13.8)

Doxycycline 0.6 mg/kg/Day vs Placebo Comparator: p = 0.807, Cochran-Mantel-Haenszel
Doxycycline 1.2 mg/kg/Day vs Placebo Comparator: p = 0.075, Cochran-Mantel-Haenszel
Doxycycline 2.4 mg/kg/Day vs Placebo Comparator: p = 0.039, Cochran-Mantel-Haenszel

Population analysed: ITT Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 Mar 2008 thru 6 Nov 2008. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Doxycycline 0.6 mg/kg/Day	0 of 64 (0%)	22 of 64 (34.4%)	Not reported
Doxycycline 1.2 mg/kg/Day	0 of 65 (0%)	20 of 65 (30.8%)	Not reported
Doxycycline 2.4 mg/kg/Day	0 of 61 (0%)	29 of 61 (47.5%)	Not reported
Placebo Comparator	1 of 67 (1.5%)	25 of 67 (37.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Angelo Secci, MD study director

Warner Chilcott

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxycycline 0.6 mg/kg/day, Doxycycline 1.2 mg/kg/day and Doxycycline 2.4 mg/kg/day in people with Acne Vulgaris, run by Warner Chilcott at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00612573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.