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Completed

NCT Number: NCT01628549

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Warner Chilcott Investigational Site, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

50 mg P005672-HCl

Drug

P005672-HCl administered as an oral capsule(s) once daily

Other names: WC3035, Sarecycline

Placebo

Drug

Dose-matched Placebo capsule administered as an oral capsule(s) once daily

Other names: Inactive

100 mg P005672-HCl

Drug

P005672-HCl administered as an oral capsule(s) once daily

Other names: WC3035, Sarecycline

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Collaborators

  • Allergan

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 26, 2012
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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