Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03669757
Other study ID # LP0155-1375
Secondary ID 2018-000140-26
Status Completed
Phase Phase 1
First received
Last updated
Start date September 27, 2018
Est. completion date February 1, 2019

Study information

Verified date February 2019
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date February 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.

- Men or women of non-child bearing potential.

Exclusion Criteria:

- Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.

- According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310 vehicle
Active substance: none
0.1% betamethasone valerate ointment (class III steroid)
Active substance: betamethasone valerate

Locations

Country Name City State
Germany Investigational Site Hamburg
Germany Investigational Site Schwerin Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall number of treatment-emergent adverse events. Up to Day 19
Primary Number of treatment-emergent application site reactions, by treatment. Up to Day 19
Primary Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units Up to Day 12
Primary Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters sodium, potassium, chloride, bicarbonate, blood urea nitrogen, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gammaGT, uric acid, calcium, phosphate, albumin, triglycerides, cholesterol, lactate dehydrogenase, total protein, creatinine, total bilirubin, direct bilirubin, indirect bilirubin Up to Day 12
Primary Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters Single parameters only to be listed if deviation from usual urine dip test, e.g., sediment, leucocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin Up to Day 12
Primary Number of subjects with abnormal clinical significant ECG evaluation Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant') Up to Day 12
Primary Number of subjects with abnormal clinically significant findings of physical examination at Day 12. Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant' Up to Day 12
Primary Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure. measured in mmHg Up to Day 12
Primary Change from baseline to Day 4, Day 8 and Day 12 in pulse. measured in beats per minute Up to Day 12
Primary Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature. measured in degrees celsius Up to Day 12
Secondary Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography) 12 days
Secondary Change from baseline to Day 12 in disease severity Clinical assessment of change in disease severity (a global assessment performed by an investigator using a 5-point score ('-1 = worsened', '0 = unchanged', '1 = slight improvement', '2 = clear improvement but not completely healed', '3 = completely healed') 12 days
See also
  Status Clinical Trial Phase
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Completed NCT03584360 - Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin Phase 2
Recruiting NCT04994951 - Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome. Phase 2
Completed NCT02888236 - LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris Phase 2
Completed NCT02533973 - Long-term Treatment of Scalp Psoriasis With Xamiol® Gel in a Large Adult Chinese Population Phase 4
Completed NCT02193815 - A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis Phase 1
Completed NCT02004847 - Blue Light for Treating Psoriasis Vulgaris N/A
Completed NCT01946386 - A Vasoconstriction Study With LEO 90100 Phase 1
Recruiting NCT01443338 - Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2 Phase 4
Completed NCT01188928 - LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs) Phase 3
Completed NCT00764751 - Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris Phase 2
Completed NCT00236171 - Evaluation of Topical Antipsoriatics in the Psoriasis Plaque Test N/A
Completed NCT04541329 - Predicting Inflammatory Skin Disease Response to IL-23 Blockade Phase 4
Completed NCT06064084 - Incretin Effect in Patients With Psoriasis and Controls
Not yet recruiting NCT06398106 - Proactive TDM Versus Standard Use of Biologics in Psoriasis Phase 4
Recruiting NCT05892640 - Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis N/A
Recruiting NCT05390515 - Psoriatic Immune Response to Tildrakizumab Phase 4
Recruiting NCT04950218 - The Psoriasis Echo Study
Completed NCT05184348 - Plexin B2 Gene Expression and Polymorphisms in Psoriasis Phase 1
Recruiting NCT04394936 - An Explorative Psoriasis Biomarker Study N/A