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Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris

15 maj 2019 uppdaterad av: Psoriasis Research Institute of Guangzhou

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris.

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of TC cream In Treating Patients with Psoriasis Vulgaris

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

88

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 11203
        • Department of Dermatology, State University of New York, Downstate Medical Center
    • Washington
      • Seattle, Washington, Förenta staterna, 98101
        • Dermatology Associates

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Age of 18-70 years old. Both men and women and members of all races and ethnic groups
  • Consistent with diagnostic criteria of stable phase psoriasis vulgaris and have at least two target lesions suitable for evaluation
  • Women of childbearing age must be using birth control strategies defined by one of the following: 1) a barrier method (condom) and/or 2) oral contraceptives, during the 8-week study period.
  • ISGA score ≥ 2 (at least mild severity)
  • BSA (stable stage group): 1%≤ to ≤20%
  • Signed a written informed consent document
  • No additional exposure to the sun

Exclusion Criteria:

  • Subjects in pregnancy, preparing for pregnancy or breast feeding
  • History of hyperergic or photosensitivity
  • History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of hepatic, kidney and hematopoietic system, or patients with psychiatric disorders
  • History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa

  • Within 4 weeks prior to randomizations, patients have taken treatment with following approved or investigational psoriasis therapies on the target lesions:

    • Topical treatments
    • PUVA, UVB or Grenz ray therapy.
    • Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressant).
    • Any types of other investigational therapies for psoriasis
  • Within 3 months prior to randomizations, patients have taken systemic treatments with retinoids or biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab).
  • Planned initiation of, or changes to, concomitant medications that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic compositions to Coumarins.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Fordon
Läkemedel: Fordon
Fordon
Aktiv komparator: TC cream (10%)
Läkemedel: TC cream
A well-characterized botanical drug for topical treatment of psoriasis vulgaris

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Investigator's Static Global Assessment Scale (ISGA) scores of target lesions
Tidsram: up to 12 weeks
ISGA is a static measurement of the psoriasis status performed by physicians. A 6-point ordinal scale from 0 (minimum) to 5 (maximum) is used for estimation with 0 representing completely clear and 5 for very severe. An ISGA score improvement of ≥2 from baseline is considered an improved outcome.
up to 12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Psoriasis Area and Severity Index (PASI) scores
Tidsram: up to 12 weeks
PASI is the most extensively used tool to measure severity of psoriasis by combing the severity of lesions (erythema, induration and desquamation) and affected area into one single score. Scale ranges from 0 (no disease) to 72 (maximal disease)
up to 12 weeks
Change in Dermatology Life Quality Index (DLQI) scores
Tidsram: up to 12 weeks
DLQI is calculated by summing the score of all questions in questionnaire to measure the impact of psoriasis on the quality of life of a patient. The score ranges from 0 (minimum) to 30 (maximum) with lower scores associated with a better quality of life.
up to 12 weeks
Change in Psoriasis Disability Index questionnaire (PDI) scores
Tidsram: up to 12 weeks
PDI is used to quantify the impact of psoriasis on quality of patients' daily life. The scale ranges from 0 (minimum) to 90 (maximum) with higher scores indicating impaired quality of life.
up to 12 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Drug-related incidence and severity of adverse events
Tidsram: week 8
Percentage of patients with incidence and adverse events related to treatment
week 8
Percentage of patients with drug-related changes in clinical laboratory results from baseline
Tidsram: week 8
Urinalysis laboratory assessments
week 8
Percentage of patients with abnormal changes in clinical laboratory results from baseline
Tidsram: week 8
Biochemistry laboratory assessments
week 8
Percentage of patients with drug-related changes in clinical laboratory results from baseline
Tidsram: week 8
Hematology and coagulation laboratory assessments
week 8
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Tidsram: week 8 and week 12
Systolic/diastolic blood pressure assessments
week 8 and week 12
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Tidsram: week 8 and week 12
Pulse rate assessments
week 8 and week 12
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Tidsram: week 8 and week 12
Respiration rate assessments
week 8 and week 12
Percentage of patients with drug-related changes in physical examination from baseline related to treatment
Tidsram: week 8 and week 12
Body temperature assessments
week 8 and week 12
Percentage of patients with drug-related changes in liver functions from baseline
Tidsram: week 8
Laboratory assessments of liver functions
week 8
Percentage of patients with drug-related changes in renal functions from baseline
Tidsram: week 8
Laboratory assessments of renal functions
week 8
Percentage of patients with drug-related changes in electrocardiography (ECG) from baseline
Tidsram: week 8
Assessments of PR/PQ intervals, QRS duration and QT intervals
week 8

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Psoriasis Research Institute of Guangzhou

Utredare

  • Huvudutredare: Edward Heilman, MD, Department of Dermatology, State University of New York
  • Huvudutredare: Peter J. Jenkin, MD, Dermatology Associates
  • Studierektor: Jiang Yang, Ph.D., Psoriasis Research Institute of Guangzhou
  • Studiestol: Liping Yang, MD, Psoriasis Research Institute of Guangzhou

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 juni 2015

Primärt slutförande (Faktisk)

14 mars 2018

Avslutad studie (Faktisk)

30 juni 2018

Studieregistreringsdatum

Först inskickad

30 november 2017

Först inskickad som uppfyllde QC-kriterierna

8 december 2017

Första postat (Faktisk)

14 december 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 maj 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 maj 2019

Senast verifierad

1 maj 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 105883-1

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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