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

JRCT ID: jRCTs061210078

Registered date:22/02/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: rosacea, rosacea-like dermatitis
• Date of first enrollment: 20/06/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Continuous topical application of delgocitinib ointment twice a day for 12 weeks

Outcome(s)

• Primary Outcome: Score of clinical manifestations eight items (hot flashes, erythema, papules pustule, telangiectasia, itch, situation, drying, edema)
• Secondary Outcome: 1)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 maximum: Not applicable
• Gender: Both

Include criteria

1)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 criteria

1)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

• Primary Sponsor: Kajita Ai