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Trial record 35 of 136 for:    tetracycline

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01628549
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : January 8, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: 50 mg P005672-HCl Drug: Placebo Drug: 100 mg P005672-HCl Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 30, 2012
Actual Primary Completion Date : November 16, 2012
Actual Study Completion Date : January 31, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: P005672-HCl approximately 0.75 mg/kg/day
One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
Drug: 50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Other Name: WC3035, Sarecycline

Drug: Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
Other Name: Inactive

Experimental: P005672-HCl approximately 1.5 mg/kg/day
Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
Drug: 50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Other Name: WC3035, Sarecycline

Experimental: P005672-HCl approximately 3.0 mg/kg/day
Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks
Drug: 100 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Other Name: WC3035, Sarecycline

Placebo Comparator: Placebo
Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
Drug: Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
Other Name: Inactive




Primary Outcome Measures :
  1. 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) ]
  2. 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.



Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline to 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

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): NCT01628549


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

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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01628549    
Other Study ID Numbers: PR-10411
First Posted: June 26, 2012    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Almirall, S.A.:
acne
Additional relevant MeSH terms:
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Tetracycline
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Sarecycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents