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

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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.




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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


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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     History of Changes
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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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tetracycline
Sarecycline
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents