Efficacy of delgocitinib ointment for skin rashes in patients with atopic dermatitis.

JRCT ID: jRCTs031230063

Registered date:01/05/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 26/06/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Delgocitinib ointment 0.5%, twice daily at the appropriate dose, applied topically to the facial or neck rash for 12 weeks. Evaluate at 1~2 weeks, 4 weeks, 8 weeks, and 12 weeks after treatment.

Outcome(s)

• Primary Outcome: Changes in patient satisfaction with treatment (TSQM-9) before and after starting delgocitinib ointment.

Secondary Outcome

Changes in skin rash at the observation site (changes in EASI and mEASI)
Evaluate changes over time in EASI and mEASI. (0 weeks, 1-2 weeks, 4 weeks, 8 weeks, 12 weeks)
Changes in itching at the observation site (changes in NRS)
Evaluate changes over time in NRS score. (0 weeks, 1-2 weeks, 4 weeks, 8 weeks, and 12 weeks)
Degree of local side effects at the observation site
Evaluate changes over time in the score. (0 weeks, 1-2 weeks, 4 weeks, 8 weeks, and 12 weeks)
The sensation of delgocitinib ointment.
Evaluate changes over time in scores for the observed site's dryness, texture, firmness, elasticity, and appearance. (0 weeks, 1-2 weeks, and 12 weeks)
Change in disease control (change in ADCT)
Evaluate changes over time in ADCT score. (0 weeks, 4 weeks, 8 weeks, and 12 weeks)
Preference for delgocitinib ointment (PPQ)
Evaluate the preference for delgocitinib ointment compared to the pre-switching topical treatment over time.
(4 weeks and 12 weeks)

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients aged 18 years and older with atopic dermatitis when obtaining consent.
(2) Patients using topical steroids or tacrolimus ointment* for face or neck rash for more than 3 months.
(3) Patients with local side effects such as skin atrophy, vasodilation, or rosacea-like dermatitis as a result of treatment with topical steroids or who are expected to use topical steroids for a long time and are concerned about the development of local side effects or patients with local side effects such as skin irritation, or rosacea-like dermatitis due to the use of tacrolimus ointment on the face or neck.
(4) Patients who have given written consent to participate in the study.
**: Any rank and formulation of topical steroids.
**: Any concentration of tacrolimus ointment.

Exclude criteria

(1) Patients using the strongest topical steroids on the face or neck.
(2) Patients using delgocitinib ointment on the face or neck.
(3) Patients using difamilast ointment.
(4) Patients with plaque or other erosions forming obvious foci at the observation site.
(5) Patients who are pregnant, may become pregnant, or plan to become pregnant during the study period.
(6) Patients who are breastfeeding
(7) Patients previously treated with delgocitinib ointment
(8) Patients receiving systemic therapy with internal medications (steroids, cyclosporine, JAK inhibitors) at the time consent was obtained or within the last 3 months.
(9) Patients receiving systemic therapy with biologics (e.g., dupilumab, nemolizumab) at the time consent was obtained or within the last 6 months
(10) Patients receiving phototherapy, such as ultraviolet light therapy, at the time consent was obtained or within the last 3 months.
(11) Patients who have participated in a clinical trial or similar within the last 6 months
(12) Patients deemed ineligible for the study by the investigator or others.

Related Information

• Primary Sponsor: Masatoshi Abe
• Secondary Sponsor: Yoshiki Miyachi
• Source(s) of Monetary Support: Torii Pharmaceutical co., Ltd