Acne VulgarisPhase 2NCT01628549

Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

A Phase 2 study testing 50 mg P005672-HCl and 100 mg P005672-HCl in people with Acne Vulgaris, run by Almirall, S.A. at 38 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

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris. 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?: 50 mg P005672-HCl and 100 mg P005672-HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 285 participants
Where: 38 sitesUnited States
Study dates: 30 Jun 2012to 31 Jan 2013
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

if women of child-bearing potential, have a negative urine pregnancy test
Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Male or female, 12-45 years of age with body weight between 52 and 88 kg
Diagnosis of acne vulgaris with:
20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)
No more than 2 nodules on the face
Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)

Who cannot join

Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:
Within 1 week prior to randomization:
Medicated facial cleansers
Topical acne treatments (other than those listed below)
Within 4 weeks prior to randomization:
Topical retinoids

Show all 14Show fewer

Topical anti-inflammatories and corticosteroids
Systemic antibiotics
Systemic acne treatments
Within 12 weeks prior to randomization:
Systemic retinoids
Systemic corticosteroids
Pseudomembranous colitis or antibiotic-associated colitis
Hepatitis, liver damage or renal impairment

Trial locations and contacts

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

United States38 sites

Warner Chilcott Investigational Site
Albuquerque, New Mexico, 87106
Warner Chilcott Investigational Site
Arlington, Texas, 76011
Warner Chilcott Investigational Site
Arlington Heights, Illinois, 60005
Warner Chilcott Investigational Site
Austin, Texas, 78759
Warner Chilcott Investigational Site
Berlin, New Jersey, 08009
Warner Chilcott Investigational Site
Boston, Massachusetts, 02135
Warner Chilcott Investigational Site
Charlotte, North Carolina, 28209
Warner Chilcott Investigational Site
Chicago, Illinois, 60611
Warner Chilcott Investigational Site
Cincinnati, Ohio, 45249
Warner Chilcott Investigational Site
Clearwater, Florida, 33761
Warner Chilcott Investigational Site
Coral Gables, Florida, 33134
Warner Chilcott Investigational Site
Fridley, Minnesota, 44532
Warner Chilcott Investigational Site
Gainesville, Florida, 32605
Warner Chilcott Investigational Site
Granger, Indiana, 46530
Warner Chilcott Investigational Site
Greer, South Carolina, 29650
Warner Chilcott Investigational Site
Hot Springs, Arkansas, 71913
Warner Chilcott Investigational Site
Houston, Texas, 77065
Warner Chilcott Investigational Site
Indianapolis, Indiana, 46256
Warner Chilcott Investigational Site
Los Angeles, California, 90045
Warner Chilcott Investigational Site
Louisville, Kentucky, 40202
Warner Chilcott Investigational Site
Lynchburg, Virginia, 24501
Warner Chilcott Investigational Site
Miami, Florida, 33175
Warner Chilcott Investigational Site
Miramar, Florida, 33027
Warner Chilcott Investigational Site
Mobile, Alabama, 36608
Warner Chilcott Investigational Site
Philadelphia, Pennsylvania, 19103
Warner Chilcott Investigational Site
Pinellas Park, Florida, 33781
Warner Chilcott Investigational Site
Plano, Texas, 75093
Warner Chilcott Investigational Site
Portland, Oregon, 97210
Warner Chilcott Investigational Site
Rochester, New York, 14609
Warner Chilcott Investigational Site
Rochester, New York, 14623
Warner Chilcott Investigational Site
Salisbury, North Carolina, 28144
Warner Chilcott Investigational Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Site
San Diego, California, 92123
Warner Chilcott Investigational Site
Sandy City, Utah, 84070
Warner Chilcott Investigational Site
Santa Monica, California, 90404
Warner Chilcott Investigational Site
St Louis, Missouri, 63117
Warner Chilcott Investigational Site
Tucson, Arizona, 85710
Warner Chilcott Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Conditions: Acne Vulgaris
Being tested: 50 mg P005672-HCl, Placebo, 100 mg P005672-HCl
Keywords: acne
Medical subject headings: Acne Vulgaris

What participants receive

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

50 mg P005672-HClDrug
Also called WC3035, Sarecycline
P005672-HCl administered as an oral capsule(s) once daily
PlaceboDrug
Also called Inactive
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
100 mg P005672-HClDrug
Also called WC3035, Sarecycline
P005672-HCl administered as an oral capsule(s) once daily

Study groups in NCT01628549
Study group	Role	What they receive
P005672-HCl approximately 0.75 mg/kg/day	Experimental	One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks Receives: Drug: 50 mg P005672-HCl; Drug: Placebo
P005672-HCl approximately 1.5 mg/kg/day	Experimental	Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks Receives: Drug: 50 mg P005672-HCl
P005672-HCl approximately 3.0 mg/kg/day	Experimental	Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks Receives: Drug: 100 mg P005672-HCl
Placebo	Placebo comparator	Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks Receives: Drug: Placebo

What is being measured

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

The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Measured: Baseline (Week 0) to Final Visit (Up to Week 12)
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.
The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Measured: Final Visit (Up to Week 12)

Secondary outcomes (5)

The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Measured: Baseline (Week 0) up to Week 12
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Measured: Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Measured: Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Measured: Baseline (Week 0) up to Week 12
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.
The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Measured: Baseline to Final Visit (Up to Week 12)

Timeline

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

30 Jun 201231 Jan 2013

First posted26 Jun 2012 (estimated)
Study start30 Jun 2012
Primary completion16 Nov 2012
Study completion31 Jan 2013

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 285 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01628549
Sponsor's protocol ID: PR-10411
Status last verified: Jan 2019
First submitted: 22 Jun 2012
Last updated: 1 Feb 2019
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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RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411
ClinicalTrials.gov ID: NCT01628549
Acronym / sponsor ID: PR-10411
Conditions: Acne Vulgaris
Keywords: acne
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 285 participants (actual)
Lead sponsor: Almirall, S.A.Industry (pharma, biotech, devices)
Collaborators: Allergan
Study start: 30 Jun 2012 (actual)
Primary completion: 16 Nov 2012 (actual)
Study completion: 31 Jan 2013 (actual)
First posted: 26 Jun 2012 (estimated)
Results: Posted 8 Jan 2019

Clinical summary

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

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
P005672-HCl approximately 0.75 mg/kg/day	Experimental	Drug: 50 mg P005672-HCl, Drug: PlaceboOne P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
P005672-HCl approximately 1.5 mg/kg/day	Experimental	Drug: 50 mg P005672-HClTwo P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
P005672-HCl approximately 3.0 mg/kg/day	Experimental	Drug: 100 mg P005672-HClTwo P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks
Placebo	Placebo comparator	Drug: PlaceboTwo Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks

Who may qualify

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

Key inclusion criteria (7 listed)

if women of child-bearing potential, have a negative urine pregnancy test
Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Male or female, 12-45 years of age with body weight between 52 and 88 kg
Diagnosis of acne vulgaris with:
20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)

Key exclusion criteria (14 listed)

Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:
Medicated facial cleansers
Topical acne treatments (other than those listed below)
Topical retinoids
Topical anti-inflammatories and corticosteroids

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
50 mg P005672-HClAlso: WC3035, SarecyclineP005672-HCl administered as an oral capsule(s) once daily	Drug	P005672-HCl approximately 0.75 mg/kg/day, P005672-HCl approximately 1.5 mg/kg/day
PlaceboAlso: InactiveDose-matched Placebo capsule administered as an oral capsule(s) once daily	Drug	P005672-HCl approximately 0.75 mg/kg/day, Placebo
100 mg P005672-HClAlso: WC3035, SarecyclineP005672-HCl administered as an oral capsule(s) once daily	Drug	P005672-HCl approximately 3.0 mg/kg/day

Primary outcome

The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Time frame: Baseline (Week 0) to Final Visit (Up to Week 12)
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
Time frame: Final Visit (Up to Week 12)
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

5 secondary outcomes

The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline to Final Visit (Up to Week 12)

Results and safety

Results posted to the registry on 8 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	73	64
P005672-HCl Approximately 0.75 mg/kg/Day	76	64
P005672-HCl Approximately 1.5 mg/kg/Day	70	60
P005672-HCl Approximately 3.0 mg/kg/Day	66	57

Primary outcome: The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit

Time frame: Baseline (Week 0) to Final Visit (Up to Week 12). Mean (Standard Deviation). Unit: Number of Inflammatory Lesions

Measure	Placebo n = 72	P005672-HCl Approximately 0.75 mg/kg/Day n = 76	P005672-HCl Approximately 1.5 mg/kg/Day n = 70	P005672-HCl Approximately 3.0 mg/kg/Day n = 66
Value	12.8 (14.18)	14.4 (13.01)	17.6 (16.65)	17.1 (11.69)

Placebo vs P005672-HCl Approximately 0.75 mg/kg/Day: Difference in Least Squares Means: 1.53 (95% CI -2.32 to 5.38), p = 0.4344, ANCOVA
Placebo vs P005672-HCl Approximately 1.5 mg/kg/Day: Difference in Least Squares Means: 4.46 (95% CI 0.52 to 8.40), p = 0.0266, ANCOVA
Placebo vs P005672-HCl Approximately 3.0 mg/kg/Day: Difference in Least Squares Means: 4.37 (95% CI 0.39 to 8.36), p = 0.0317, ANCOVA

Population analysed: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population.

Primary outcome: The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit

Time frame: Final Visit (Up to Week 12). Count of participants. Unit: Participants

Measure	Placebo n = 72	P005672-HCl Approximately 0.75 mg/kg/Day n = 76	P005672-HCl Approximately 1.5 mg/kg/Day n = 70	P005672-HCl Approximately 3.0 mg/kg/Day n = 66
Success	8	11	17	10
Failure	64	65	53	56

Placebo vs P005672-HCl Approximately 0.75 mg/kg/Day: Difference vs placebo in success rate: 3.4 (95% CI -7.82 to 14.38), p = 0.3300, Cochran-Mantel-Haenszel
Placebo vs P005672-HCl Approximately 1.5 mg/kg/Day: Difference vs placebo in success rate: 13.2 (95% CI 0.54 to 25.60), p = 0.0159, Cochran-Mantel-Haenszel
Placebo vs P005672-HCl Approximately 3.0 mg/kg/Day: Difference vs placebo in success rate: 4.1 (95% CI -7.44 to 15.87), p = 0.4834, Cochran-Mantel-Haenszel

Population analysed: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Screening (up to week -12) to Week 12 plus 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 73 (0%)	13 of 73 (17.8%)	Not reported
P005672-HCl Approximately 0.75 mg/kg/Day	0 of 76 (0%)	15 of 76 (19.7%)	Not reported
P005672-HCl Approximately 1.5 mg/kg/Day	0 of 70 (0%)	8 of 70 (11.4%)	Not reported
P005672-HCl Approximately 3.0 mg/kg/Day	0 of 66 (0%)	7 of 66 (10.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation

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.

Herman Ellman, MD study director

Warner Chilcott

38 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 50 mg P005672-HCl and 100 mg P005672-HCl in people with Acne Vulgaris, run by Almirall, S.A. at 38 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 7 inclusion and 14 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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 8 Jan 2019). 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?

The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit (time frame: Baseline (Week 0) to Final Visit (Up to 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 NCT01628549.

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 1 Feb 2019; AzTrials last refreshed its copy on 30 Oct 2026.