NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061210078

Registered date:22/02/2022

The efficacy of delgocitinib ointment for rosacea and rosacea-like dermatitis

Basic Information

Recruitment status Suspended
Health condition(s) or Problem(s) studiedrosacea, rosacea-like dermatitis
Date of first enrollment20/06/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Continuous topical application of delgocitinib ointment twice a day for 12 weeks

Outcome(s)

Primary OutcomeScore of clinical manifestations eight items (hot flashes, erythema, papules pustule, telangiectasia, itch, situation, drying, edema)
Secondary Outcome1)presence or absence of adverse events 2) EASI score 3) NRS 4)IGA 5) Skindex-16 6)presence or absence of demodex

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1)Patients aged 20 years or over at the time of agreement 2)Patient who have agreed by their own decision, with the written consent form, following the appropriate procedure of informed- consent. 3)Patient diagnosed as rosacea or rosacea-like dermatitis. 4)Patient that with refractory rosacea or rosacea-like dermatitis despite the standard treatments for 12 weeks or more 5)Patient without a history of delgocitinib ointment therapy
Exclude criteria1)Patient who have previously been treated with delgocitinib ointment. 2)Patients with any of the following disease to be differentiated: seborrheic dermatitis, atopic dermatitis (rosacea-like dermatitis arising in a patient with atopic dermatitis is not excluded), contact dermatitis, acne vulgaris, dermatomyositis, lupus erythematosus, drug eruption, lupus miliaris disseminatus faciei, eosinophilic pustular folliculitis, dermatomycosis and photo-allergy. 3)Miscellaneous: Patient who are considered ineligible for enrolling the study by a principal investigator or co-investigators.

Related Information

Contact

Public contact
Name Ai Kajita
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City Okayama Japan 700-8558
Telephone +81-86-235-7282
E-mail gmd421029@s.okayama-u.ac.jp
Affiliation Okayama University Hospital
Scientific contact
Name Ai Kajita
Address 2-5-1 Shikata-cho, Kita-ku, Okayama City Okayama Japan 700-8558
Telephone +81-86-235-7282
E-mail gmd421029@s.okayama-u.ac.jp
Affiliation Okayama University Hospital