Clinical study of Dovobet Foam in patients with prurigo nodularis

JRCT ID: jRCTs061240121

Registered date:10/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: prurigo nodularis
• Date of first enrollment: 10/02/2025
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Dovobet Foam(Calcipotriol Hydrate Betamethasone Dipropionate)
Apply an appropriate amount to the diseased area once a day for 8 weeks.

Outcome(s)

Primary Outcome

Percentage change in the number of prurigonodularis m at 8 weeks after the start of topicalDovobet Foam
(Mean value +/- standard deviation: %)

Secondary Outcome

1. Percentage change in the number of prurigo nodules at 1 and 4 weeks after the start of topicalDovobet Foam and at 2 weeks after the end of treatment.
(Mean value +/- standard deviation: %)
2. Scratch score (PP-NRS: Peak PruritusNumerical Rating Scale)
Calculate the rate of change in PP-NPS from baseline to weeks 1, 4, and 8, and 2 weeks after the end of treatment.
(Mean value +/- standard deviation: %)
Also, the percentage of subjects whose PP-NPS improved by 4 or more.
3. Sleep disturbance NRS (Numerical Rating Scale)
Calculate the rate of change in sleep disorder NRS from baseline to 1, 4, 8, and 2 weeks after the end of administration
(Mean value +/- standard deviation: %)
Also, the percentage of subjects whose sleep disorder NRS improved by 4 or more.
4. PN-IGA (Purigo Nodularis-Investigator's Global Assessment)
Calculate the rate of change in PN-IGA from baseline to weeks 1, 4, and 8, and 2 weeks after the end of treatment.
(Mean value +/- standard deviation: %)
Also, the percentage of subjects whose PN-IGA improved by 4 or more.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be considered eligible for the study.
1. After being informed of a full explanation on the participation in the present study, the patients have given written consent of their own free will based on sufficient understanding.
2. The individual must be 18 years of age or older when providing consent.
3. The patient has been diagnosed with prurigo nodularis.
4. There are three or more prurigo nodules per site.
5. Patient has persistent symptoms that have not improved with standard treatment (8 weeks or more) for prurigo nodularis.

Exclude criteria

Patients who meet any of the following criteria will not be included in this study
1. Patient has been diagnosed with prurigo-type atopic dermatitis, pemphigoid nodularis, prurigo chronica multiformis or prurigo gestationis.
2. Has used Dovobet Foam within 1 year of registration.
3. Patients with hypersensitivity to any ingredient of this drug
4. Bacterial, fungal, spirochete, or viral skin infections and parasitic skin diseases (scabies, hair lice, etc.)
5. Ulcers (except Behcet's disease), burns and frostbite of second-degree depth or greater [skin regeneration may be inhibited and healing may be delayed].
6. Other conditions that the principal investigator and the subinvestigator(s) deem inappropriate from a scientific and ethical standpoint as research subjects for this study.

Related Information

• Primary Sponsor: Hirai Yoji