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

31. januar 2019 oppdatert av: Almirall, S.A.

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

285

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 45 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Andre navn:
  • WC3035, Sarecycline
Legemiddel: Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
Andre navn:
  • Inaktiv
Eksperimentell: P005672-HCl approximately 1.5 mg/kg/day
Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
Legemiddel: 50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Andre navn:
  • WC3035, Sarecycline
Eksperimentell: P005672-HCl approximately 3.0 mg/kg/day
Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks
Legemiddel: 100 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Andre navn:
  • WC3035, Sarecycline
Placebo komparator: Placebo
Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
Legemiddel: Placebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
Andre navn:
  • Inaktiv

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Tidsramme: Baseline (Week 0) to Final Visit (Up to Week 12)
Baseline (Week 0) to Final Visit (Up to Week 12)
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
Tidsramme: 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.
Final Visit (Up to Week 12)

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Almirall, S.A.

Samarbeidspartnere

Allergan

Etterforskere

  • Studieleder: Herman Ellman, MD, Warner Chilcott

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juni 2012

Primær fullføring (Faktiske)

16. november 2012

Studiet fullført (Faktiske)

31. januar 2013

Datoer for studieregistrering

Først innsendt

22. juni 2012

Først innsendt som oppfylte QC-kriteriene

22. juni 2012

Først lagt ut (Anslag)

26. juni 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PR-10411

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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