Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

31. januar 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

285

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 45 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Almirall, S.A.

Samarbejdspartnere

Allergan

Efterforskere

  • Studieleder: Herman Ellman, MD, Warner Chilcott

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juni 2012

Primær færdiggørelse (Faktiske)

16. november 2012

Studieafslutning (Faktiske)

31. januar 2013

Datoer for studieregistrering

Først indsendt

22. juni 2012

Først indsendt, der opfyldte QC-kriterier

22. juni 2012

Først opslået (Skøn)

26. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PR-10411

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Acne Vulgaris

Kliniske forsøg med 50 mg P005672-HCl

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner