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Trial record 35 of 151 for:    tetracycline

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.

Tracking Information
First Submitted Date  ICMJE June 22, 2012
First Posted Date  ICMJE June 26, 2012
Results First Submitted Date  ICMJE December 18, 2018
Results First Posted Date  ICMJE January 8, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE June 30, 2012
Actual Primary Completion Date November 16, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2012)
  • Inflammatory Lesion Count, Absolute Change from Baseline [ Time Frame: Week 12 ]
    Sum of inflammatory lesions (nodules [palpable solid lesion > 0.5 cm with depth, not necessarily elevated], papule [ solid, elevated lesion <0.5 cm] & pustules [elevated lesion containing pus < 0.5 cm]) found on the forehead, left & right cheeks, nose and chin
  • Dichotomized IGA (Investigator's Global Assessment) Score, Change from Baseline [ Time Frame: Week 12 ]
    IGA Scale 0/clear-clear skin no inflammatory or noninflammatory lesions, 1/almost clear-rare noninflammatory lesions, no more than 1 small inflammatory lesion, 2/mild->than 1 with some noninflammatory lesions, no more than a few inflammatory lesions [papules/pustules only, no nodular lesions], 3/moderate->2, up to many noninflammatory lesions & may have some inflammatory lesions,no more than 1 small nodular lesion, 4/severe- >3, up to many noninflammatory & noninflammatory lesions, but no more than a few nodular lesions.
Change History Complete list of historical versions of study NCT01628549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2012)
  • Inflammatory Lesion Count, Percent Change from Baseline [ Time Frame: Week 12 ]
    Sum of inflammatory lesions on the forehead, left & right cheeks, nose and chin. Calculated as Baseline value minus post-Baseline value divided by Baseline value, expressed as a percentage.
  • Noninflammatory Lesion Count, Percent Change from Baseline [ Time Frame: Week 12 ]
    Sum of non-inflammatory lesions (open [blackhead] & closed [whitehead] comedones) found on the forehead, left & right cheeks, nose and chin. Calculated as Baseline value minus post-Baseline value divided by Baseline value, expressed as a percentage.
  • Noninflammatory Lesion Count, Absolute Change from Baseline [ Time Frame: Week 12 ]
    Sum of non-inflammatory lesions on the forehead, left & right cheeks, nose and chin. Calculated as Baseline value minus post-Baseline value.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • 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
  • Drug: 100 mg P005672-HCl
    P005672-HCl administered as an oral capsule(s) once daily
    Other Name: WC3035, Sarecycline
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: 50 mg P005672-HCl
    • Drug: Placebo
  • Experimental: P005672-HCl approximately 1.5 mg/kg/day
    Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
    Intervention: Drug: 50 mg P005672-HCl
  • Experimental: P005672-HCl approximately 3.0 mg/kg/day
    Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks
    Intervention: Drug: 100 mg P005672-HCl
  • Placebo Comparator: Placebo
    Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2013)
285
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2012)
280
Actual Study Completion Date  ICMJE January 31, 2013
Actual Primary Completion Date November 16, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01628549
Other Study ID Numbers  ICMJE PR-10411
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Almirall, S.A.
Study Sponsor  ICMJE Almirall, S.A.
Collaborators  ICMJE Allergan
Investigators  ICMJE
Study Director: Herman Ellman, MD Warner Chilcott
PRS Account Almirall, S.A.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP