| CTRI Number |
CTRI/2020/05/025197 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking safety and effectiveness of Apremilast tablets in patients with Lichen Planus, an inflammatory disorder that appears as purplish, flat-topped bumps when it affects the skin. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of apremilast in management of lichen planus. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishalakshi Viswanath |
| Designation |
Professor and Head of Department |
| Affiliation |
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital |
| Address |
Department of dermatology, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane Municipal Corporation, Kalwa, Thane.
Thane
MAHARASHTRA
400605
India
Thane
MAHARASHTRA
400605
India |
| Phone |
9324086679 |
| Fax |
|
| Email |
drvishalakshiviswanath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishalakshi Viswanath |
| Designation |
Professor and Head of Department |
| Affiliation |
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital |
| Address |
Department of dermatology, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane Municipal Corporation, Kalwa, Thane.
Thane
MAHARASHTRA
400605
India
Thane
MAHARASHTRA
400605
India |
| Phone |
9324086679 |
| Fax |
|
| Email |
drvishalakshiviswanath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishalakshi Viswanath |
| Designation |
Professor and Head of Department |
| Affiliation |
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital |
| Address |
Department of dermatology, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane Municipal Corporation, Kalwa, Thane.
Thane
MAHARASHTRA
400605
India
Thane
MAHARASHTRA
400605
India |
| Phone |
9324086679 |
| Fax |
|
| Email |
drvishalakshiviswanath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Limited Glenmark House BD Sawant Marg Andheri East Mumbai 400099 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital |
| Address |
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital Thane Municipal Corporation Kalwa Thane 400605 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishalakshi Viswanath |
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital |
Department of Dermatology, Room No 5, Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital, Thane Municipal Corporation, Kalwa, Thane, 400605
Thane
MAHARASHTRA
Thane
MAHARASHTRA |
9324086679
drvishalakshiviswanath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L438||Other lichen planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apremilast |
Day 1: 10mg AM Day 2: 10mg AM, 10 mg PM Day 3: 10mg AM, 20 mg PM Day 4: 20mg AM, 20 mg PM Day 5: 20mg AM, 30 mg PM Day 6: 30mg AM, 30 mg PM 30mg twice a day from day 7 until week 12 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female patients aged ≥ 18 years and ≤ 60 years.
2. Patients with history of cutaneous or mucosal lichen planus.
3. Patients with a PGA score of 3 or more.
4. Patients with biopsy/dermoscopy confirmed lichen planus.
5. Patients who are candidates for systemic therapies.
6. Patients who are refractory to treatment with topical corticosteroids.
7. Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol.
|
|
| ExclusionCriteria |
| Details |
1. Patients with lichen sclerosis et atrophicus (LS&A)
2. Clinical history and lesion distribution suspicious for a lichenoid drug eruption
3. Pregnant or nursing females.
4. Other skin disease that might interfere with lichen planus assessments.
5. Patients with known hypersensitivity to the study drugs.
6. Patients with immunosuppressive disease or on immunosuppressive drugs.
7. Patients with liver dysfunction.
8. Patients with a history of seizures
9. Patients with history of psychiatric disorders.
10. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
11. Active severe infections, or prior infection requiring hospitalization or oral/intravenous antibiotics within 4 weeks before screening visit, or between the screening and baseline visits.
12. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
13. History of drug or alcohol dependency or abuse within approximately the last 2 years.
14. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
15. Any patient whom the investigator judged to be inappropriate for this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary efficacy endpoints: Primary end point the study will be the proportion of patients who achieve a significant clinical response in cutaneous disease, defined as a 2-grade or more improvement in the physician global assessment (PGA) score after 12 weeks of treatment. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The proportion of patients who achieve a significant clinical response in mucosal disease, defined as a 2-grade or more improvement in the physician global assessment (PGA) score
Proportion of patients achieving subject global assessment (SGA) of complete resolution or marked improvement
Change in mean target area lesion symptom score from baseline
|
12 weeks |
‘Target area’ is defined as the part of the body with the greatest disease severity; its boundaries are clearly defined and documented at baseline to facilitate future assessments.
Change in mean target lesion symptom score – erythema
Change in mean target lesion symptom score – elevation.
Change in mean target lesion symptom score – pruritus
|
12 weeks |
Safety
Proportion of patients discontinuing therapy with apremilast during study period.
Proportion of patients experiencing 1 or more adverse events during 12 weeks of treatment.
The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal will be summarized by treatment groups
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Lichen planus (LP) is a chronic inflammatory
disease that typically affects the skin, mucous membranes, and nails. It is
usually associated with significant morbidity such as severe pruritus and pain.
The exact cause of lichen planus is unclear however the pathogenesis of lichen
planus involves genetic and immune mediated factors predominantly T-cell
mediated inflammatory agents, such as tumor necrosis factor-α and interferon-γ.
LP lesions can have a relapsing and remitting clinical course that are very difficult
to treat.
Mainstay treatment options for management of
lichen planus are topical and oral corticosteroids, retinoids, cyclosporine,
griseofulvin, dapsone, and phototherapy. However, these therapies are often
associated with less than optimal results and significant adverse side effects.
Considering the paucity of available efficacious agents and the severity of
clinical symptoms, there is need for novel efficacious and safer agent in
management of lichen planus.
Apremilast is a selective phosphodiesterase 4
inhibitor, associated with accumulation of intracellular cyclic adenosine
monophosphate (cAMP) levels. Increased levels of cAMP activate protein kinase A
and effectively inhibit proinflammatory cytokine transcription and neutrophil
degranulation, chemotaxis, and adhesion to endothelial cells. Ultimately,
Apremilast inhibits the production of various inflammatory mediators, such as
tumor necrosis factor-α, interferon-γ, leukotriene B4, and interleukin (IL)-2,
IL-5, IL-8, and IL-12.
Since Apremilast modulates inflammatory signalling
pathways which plays a central role in the pathogenesis of lichen planus, it is
plausible that Apremilast may be an effective treatment for lichen planus. We
are planning to conduct this trial with the objective to evaluate the overall
efficacy and safety of oral Apremilast in patients with lichen planus. |