Nodular Prurigo
Conditions
Interventions
<
Steroid-treated group>
The subjects will be randomized into 2 groups (right or left) after topical application of steroid drugs for 2 weeks (observation period), then will be applied steroid drugs for 6 weeks (treatment per
Moisturizer combination group>
The subjects will be randomized into 2 groups (right or left) after topical application of steroid drugs for 2 weeks (observation period). After 2 week topical application of steroid and moisturizer
Sponsors
Tokyo Medical and Dental University Department of Dermatology (main research institute)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged over 20 years or older on the day of signing informed consent form. (2) Sex: Either male or female, Patient status: Inpatient or outpatient (3) Patients with the ability to assent participation in this clinical study and sign informed consent form. (4) Patients with the same levels of nodular prurigo on left and right arms or legs. Patients with two separated target areas in trunk can also participate in this study.
Exclusion criteria
Exclusion criteria: (1) Patients with itchy condition other than nodular prurigo (2) Patients with ulcer, erosion and eczema caused by scratching in the target areas (3) Patients who are associated with severe (rash areas with strong inflammation are over 10% of BSA) or very severe form of atopic dermatitis (4) Patients with history of allergy to topical drugs (5) Patients with the following concurrent diseases: Clinically significant liver, kidney, heart, lungs or blood diseases that require hospitalization (6) Patients with kidney failure or kidney dysfunction (7) Patients who have participated in any clinical trial or clinical study within one month before clinical study starts (8) Patients who are judged to be inappropriate as a subject by the investigator or subinvestigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Evaluation of efficacy <Evaluation of severity> The severity of nodular prurigo will be evaluated in accordance with the 4 levels of criteria (none, mild, moderate and severe) for each indicator of the severity (keratinization, thickening, scraping and drying). <Evaluation of itch> The itch intensity of subjects will be evaluated in accordance with the visual analogue scale (VAS) and itch score (5 levels). (2) Evaluation of safety <Subjective and objective symptom> Following things occurred in the study will be studied. Adverse event description, seriousness (mild, moderate and severe), date of onset, action taken for adverse event, outcome (process and date of confirmation of outcome) and causal relationship to the study drug (Yes or No). | — |
Countries
Japan
Contacts
Public ContactKenji Kabashima
Kyoto University, Graduate School of Medicine Department of Dermatology
Outcome results
None listed