Accelerating Patient Recruitment: Topical Tacrolimus for Atopic Dermatitis
07 Jul 2023
Successful Enrolment of 783 Patients across India, in Two Phase III Studies on Topical Tacrolimus for Atopic Dermatitis in Just 5 Months.
Background:
- Atopic dermatitis (AD) is a prevalent chronic inflammatory skin condition characterized by itchy, eczematous lesions and small blisters.
- Treatment goals for AD include managing dry skin, reducing inflammation, controlling itching, promoting healing, preventing infections, and minimizing flares. Long-term use of topical glucocorticoids is the primary treatment for AD but is associated with adverse drug effects (ADRs) such as irreversible skin atrophy.
- Tacrolimus, an immunomodulator, is a safe and effective non-corticosteroid alternative for treating AD.
- The study sponsor approached Lambda to support site enrolment for Phase III study for Tacrolimus Ointment in atopic dermatitis.
Study Details:
- Lambda conducted two randomized, double-blind, vehicle-controlled, multi-center Phase-III studies to evaluate the efficacy and safety of topical tacrolimus in patients with moderate-to-severe atopic dermatitis.
- Study-1: 0.1% Tacrolimus Topical Ointment
- Study-2: 0.03% Tacrolimus Topical Ointment
- The studies involved the application of tacrolimus topical ointment twice daily to a defined symptomatic area of 200 to 1000 cm2 of skin for a duration of three weeks.
Challenges Overcame:
- Limited Awareness: Atopic dermatitis may be underdiagnosed or misdiagnosed, requiring increased awareness to educate patients and healthcare providers about the condition.
- Stringent Eligibility Criteria: The recruitment process involved meticulous screening of participants who met specific criteria related to disease duration, affected area, and severity. These criteria included a minimum disease history of three months, a specified body surface area (BSA) for the affected area of atopic dermatitis, adherence to the severity range of moderate to severe according to the Hanifin and Rajka criteria, and a validated Investigator Global Assessment (vIGA) scoring system indicating at least moderate disease severity.
- Patient Engagement: Maintaining patient engagement throughout the study duration was crucial to minimize dropouts and ensure adherence to the treatment protocol.
Our Approach:
- Successfully tackled challenges related to stringent eligibility criteria, awareness, and patient engagement, employing effective strategies to ensure a diverse and representative study population.
- Effective engagement with sites from the beginning of the studies to identify and recruit eligible patients.
- Providing comprehensive training to sites on the necessary scales and scoring systems required for these studies.
Outcome:
- 783 patients from across India were successfully recruited in just five months.
Study-10.1% Tacrolimus Topical Ointment 429 Patients 19 Sites |
Study-20.03% Tacrolimus Topical Ointment 354 Patients 17 Sites |
- The achievement of recruiting a substantial number of patients within a short timeframe demonstrates Lambda's effective patient outreach and engagement strategies.
Dermatology Excellence: A Proven Track Record
Accelerate your dermatology clinical trials with Lambda & Novum's extensive experience.
| Dermatology Studies | Patients | Sites |
|---|---|---|
| 80 | 33195 | 1412 |
Contact us to leverage our proven track record of excellence and expedite your dermatology research.