- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00764751
Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris
LEO 19123 Cream in the Treatment of Psoriasis Vulgaris
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
-
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Ontario
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Barrie, Ontario, Kanada, L4M 6L2
- Ultranova Skincare
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Signed and dated informed consent to be obtained prior to any trial related procedure, including washout.
- Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs with a symmetrical distribution amenable to treatment with a maximum of 50 g/week of topical medication on each side of the body. At Visit 1, there should not be a difference between the right and left side of more than 1 for each of the PASI criteria (redness, thickness and scaliness).
- A minimum PASI score for extent of 2 on each side in at least one body region (i.e. psoriasis affecting at least 10% of left and right arm, and/or 10% of left and right side of the trunk, and/or 10% of left and right leg).
- Disease severity graded mild, moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity on each side of the body. The assessment should be the same for both sides of the body.
- Age 18 years or above
- Male subjects, or females of non-childbearing potential (i.e. surgically sterile or at least two years postmenopausal)
- Attending a hospital outpatient clinic or the private practice of a dermatologist
Exclusion Criteria:
- Subjects using systemic treatments with biological therapies with a possible effect on psoriasis vulgaris within 12 weeks prior to randomisation (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab)
- Systemic treatment with all other therapies, besides biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation (inhaled or intranasal steroids for asthma or rhinitis may be used)
- PUVA or Grenz ray therapy within 4 weeks prior to randomisation
- UVB therapy within 2 weeks prior to randomisation
- Any topical treatment (except for emollients) of the trunk/limbs (except on flexures) within 2 weeks prior to randomisation
- Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with potent or very potent (WHO group III-IV) corticosteroids, vitamin D analogues or retinoids within 2 weeks prior to randomisation
- Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with very potent (WHO group IV) corticosteroids, vitamin D analogues or retinoids within 2 weeks prior to randomisation
- Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) within 2 weeks prior to randomisation
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation
- Subjects with current participation in any other interventional clinical trial
- Subjects with any of the following conditions present on the treatment area: eczematous skin, atopic dermatitis, clinical infection, ulcers and wounds
- Subjects with a history of serious allergy, allergic skin rash or sensitivity to any component of the investigational products or formulations being tested
- Subjects with positive hepatitis B, C or HIV
- Known or suspected severe renal insufficiency or severe hepatic disorders
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia
- Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
- Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light should be avoided)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 1
|
Once daily application
|
Active Comparator: 2
|
Twice daily application
|
Placebo Comparator: 3
|
Twice daily application
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
The Percentage Change in PASI (Psoriasis Area Severity Index)
Aikaikkuna: From baseline (Day 0) to end of treatment (Day 28)
|
The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here. |
From baseline (Day 0) to end of treatment (Day 28)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Investigator's Global Assessment of Disease Severity
Aikaikkuna: At end of treatment (Day 28)
|
At all visits the (sub)investigator made a global assessment of the disease severity for psoriasis on the left and right side, respectively, of the body by use of the 6-point scale below. These assessments were to represent the average lesion severity on the left and right side, respectively. These assessments were to be based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit. Clear Almost clear Mild Moderate Severe Very severe |
At end of treatment (Day 28)
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Participants With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity
Aikaikkuna: At end of treatment (Day 28)
|
For subjects with a baseline (Visit 1) severity of moderate or worse, "controlled disease" is defined as "clear" or "almost clear" according to the Investigator's global assessment of disease severity.
For subjects with a baseline (Visit 1) severity of mild, "controlled disease" is defined as "clear" according to the Investigator's global assessment of disease severity.
|
At end of treatment (Day 28)
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Participant's Overall Assessment of Treatment Response
Aikaikkuna: At end of treatment (Day 28)
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The participant assessed the treatment response by use of the 6-point scale below. Worse Unchanged Slight improvement Moderate improvement Marked improvement Almost clear Cleared |
At end of treatment (Day 28)
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Participant's Assessment of Treatment Preference
Aikaikkuna: At end of treatment (Day 28)
|
At end of treatment (Day 28)
|
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Participants With at Least 75% Reduction in PASI (PASI 75)
Aikaikkuna: From baseline (Day 0) to end of treatment (Day 28)
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From baseline (Day 0) to end of treatment (Day 28)
|
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Participants With at Least 50% Reduction in PASI (PASI 50)
Aikaikkuna: From baseline (Day 0) to end of treatment (day 28)
|
From baseline (Day 0) to end of treatment (day 28)
|
|
The Absolute Change in PASI (Psoriasis Area Severity Index)
Aikaikkuna: From baseline to end of treatment (Day 28)
|
The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here. |
From baseline to end of treatment (Day 28)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Rodion Kunynetz, MD, Ultranova Skincare
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- LEO 19123-C24
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Kliiniset tutkimukset Psoriasis Vulgaris
-
Chinese University of Hong KongEi vielä rekrytointiaPsoriasis Vulgaris
-
University Hospital, GhentRekrytointiPsoriasis VulgarisBelgia
-
University Hospital, GhentRekrytointiPsoriasis VulgarisBelgia
-
University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRekrytointiPsoriasis VulgarisYhdysvallat
-
University of California, San FranciscoSun Pharmaceutical Industries LimitedRekrytointi
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Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsRekrytointi
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University Hospital, GhentKU Leuven; University GhentRekrytointiPsoriasis VulgarisBelgia
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University of California, San FranciscoNational Psoriasis FoundationRekrytointiPsoriasis | Psoriasis VulgarisYhdysvallat
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University Hospital, GhentKU Leuven; University GhentValmisPsoriasis VulgarisBelgia
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University Hospital, GhentKU Leuven; University GhentValmisPsoriasis VulgarisBelgia
Kliiniset tutkimukset LEO 19123 Cream (calcipotriol plus LEO 80122)
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LEO PharmaLopetettuAtooppinen ihottumaSaksa
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LEO PharmaValmis
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LEO PharmaValmis
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LEO PharmaValmis
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LEO PharmaValmisPsoriasis VulgarisRanska
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LEO PharmaValmis
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LEO PharmaValmisIho- ja sidekudostauditRanska