Topical Use of 2% Tofacitinib for Nail Psoriasis: an Exploratory Clinical Study
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Hexsel Dermatology Clinic
- Enrollment
- 10
- Primary Endpoint
- The efficacy of topical 2% tofacitinib
Overview
Brief Summary
To evaluate the efficacy and safety of topical 2% tofacitinib nail lacquer in nail psoriasis, using the NAPSI and DLQI scales before and after 26 weeks of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years;
- •Presence of nail psoriasis in at least one fingernail or toenail;
- •Patients not using systemic medication, or without adequate response to systemic medication after at least 6 months of use;
- •Ability to read, understand, and sign the Informed Consent Form (ICF) and the Consent Form for Images, Presentations, and Scientific Publications.
Exclusion Criteria
- •Pregnant or breastfeeding women or those planning to become pregnant during the study period;
- •History of sensitivity to any components of the study product;
- •Initiation of systemic medication for nail psoriasis less than six months prior.
Arms & Interventions
Medicated Nail Lacquer
Intervention: Topical 2% Tofacitinib (Drug)
Outcomes
Primary Outcomes
The efficacy of topical 2% tofacitinib
Time Frame: 26 weeks
The Nail Psoriasis Severity Index (NAPSI) evaluates nail psoriasis severity by assessing a target nail for nail matrix and nail bed involvement. The nail is divided into four quadrants. Nail matrix psoriasis includes pitting, leukonychia, red spots in the lunula, and nail plate crumbling, while nail bed psoriasis comprises onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and nail bed hyperkeratosis. Each component is scored from 0 to 4 according to the number of quadrants affected (1 = 1/4, 2 = 2/4, 3 = 3/4, 4 = 4/4). The total NAPSI score per nail is calculated as the sum of matrix and nail bed scores, ranging from 0 to 8. The score is directly proportional to disease severity, with higher scores indicating greater nail involvement and a score of zero representing absence of nail manifestations. In clinical studies, a decrease in NAPSI score over time indicates clinical improvement.
Secondary Outcomes
- Safety, Quality of Life, and Treatment Adherence with 2% Tofacitinib(26 weeks)
Investigators
Doris Hexsel
Dr
Hexsel Dermatology Clinic