Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Roflumilast 0.3 percent w/w Cream
: Route: Topical
Once daily to affected areas of plaque psoriasis. For topical use only. Not for
ophthalmic, oral, or intravaginal use.
Total study pe
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharma Laboratories Ltd SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to provide written informed consent 2. Patients with a confirmed clinical diagnosis of plaque psoriasis (psoriasis vulgaris) fulfilling the following criteria at Screening: a) Patient was diagnosed at least 6 months prior to Screening b) The lesions must involve the trunk and or extremities [excluding face, scalp, palms, soles and intertriginous areas] and is amenable to topical treatment c) The affected area should be greater than or equal to 2 percent to less than or equal to 20 percent of body surface area (BSA) d) Psoriasis Area Severity Index (PASI) score of greater than or equal to 2 at Screening e) Stable disease (without any new lesions or progression of existing lesions) in last 4 weeks prior to Screening and during Screening and washout period 3. Patients who agree to discontinue all agents used to treat plaque psoriasis from Screening through the EOS visit 4. Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide]) 5. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period]
Exclusion criteria
Exclusion criteria: Patient will be excluded if any of the exclusion criteria listed below is met: 1. Patients with known hypersensitivity or any other contraindication to any of the Investigational products or its component 2. Patients with unstable forms of psoriasis (for example but not limited to: guttate, erythrodermic, pustular psoriasis, palmoplantar psoriasis, drug-induced psoriasis, etc.) 3. Patients with history of any other skin disorder (for example but not limited to: pigmentation, extensive scarring, pigmented lesions, sunburn, acne, ulcer, atrophic striae, ichthyosis, etc.), that in the opinion of Investigator, would interfere with the study medication application or efficacy and safety assessments 4. Patients with history of Vitamin D toxicity 5. Patients with previous treatment with topical Roflumilast or topical calcipotriol 6. Patients using any of the following drugs/ treatments: a. Strong CYP450 inhibitors (like: ketoconazole, itraconazole, ritonavir, indinavir, clarithromycin, etc.) [Note: Patients can be included after 2 weeks of washout period] b. Strong CYP450 inducers (like: barbiturates, nevirapine, phenytoin, rifampicin, etc.) [Note: Patients can be included after 2 weeks of washout period] c. Topical agents for psoriasis (including but not limited to: corticosteroids [Class 1, 2 and 3], Vitamin D analogues, retinoids, PDE4 inhibitors, salicylic acid, pimecrolimus, tacrolimus, anthralin, tar, etc.) [Note: Patients can be included after 2 weeks of washout period] d. Topical Class 4 corticosteroids [Note: Patients can be included after 4 weeks of washout period] e. Systemic immunosuppressing agents (like fumaric acid, corticosteroids, methotrexate, retinoids, PDE4 inhibitors [including oral Roflumilast], cyclosporine, etc.) [Note: Patients can be included after 4 weeks of washout period] f. Any type of Laser or Phototherapy [Note: Patients can be included if they have completed 4 weeks of washout period] g. Biological agents [Note: Patients can be included if they have completed 8 weeks or 5 half-lives (whichever is longer) of washout period post-last dose] 7. Patients with history of any clinically significant medical and or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results [for example but not limited to: hepatic impairment (if ALT greater than or equal to 3 x upper limit of normal [ULN] OR AST greater than or equal to 3 x ULN OR ALP greater than or equal to 3 x ULN OR total bilirubin greater than or equal to 1.5 x ULN), renal impairment (Serum creatinine greater than or equal to 2 x ULN), hypercalcemia (serum calcium greater than or equal to 12 mg/dL), epilepsy or seizure disorder or any neurological disorder, uncontrolled diabetes (HbA1c greater than or equal to 9 percent)] 8. Pregnant and or lactating female 9. Patients with history of severe depression or suicidal ideation 10. Patient with positive report of human immunodeficiency virus (HIV) and/or hepatitis B virus (HbsAg) and/or hepatitis C virus (HCV) infection at Screening 11. Patients with history of any malignancy in the last 5 years prior to Screening or undergoing cancer chemo or radiotherapy 12. Patients with known alcohol or other substance abuse within last one year prior to Screening 13. Patients who have parti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving 75% reduction from baseline in PASI score (PASI-75)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving 50% reduction from baseline in PASI score (PASI-50)Timepoint: ;Proportion of patients achieving 90% reduction from baseline in PASI score (PASI-90)Timepoint: ;Percentage change from baseline in PASI scoreTimepoint: ;Percentage change from baseline in affected BSATimepoint: ;Proportion of patients achieving a score of â??0â? or â??1â? in Investigatorâ??s Global Assessment of Disease (IGA) scale Timepoint: ;Change from baseline in DLQI total scoreTimepoint: ;Proportion of participants with treatment emergent (TEAEs) and serious adverse events (SAEs)Timepoint: ;Proportion of patients achieving 75% reduction from baseline in PASI score (PASI-75)Timepoint: Week 24 and 36 ;Proportion of patients achieving 50% reduction from baseline in PASI score (PASI-50) Timepoint: Week 24 and 36;Proportion of patients achieving 90 % reduction from baseline in PASI score (PASI-90) Timepoint: Week 24 and 36.; Percentage change from baseline in PASI score.Timepoint: ; Percentage change from baseline in affected BSATimepoint: ;Proportion of patients achieving a score of â??0â? or â??1â? in Investigatorâ??s Global Assessment of Disease (IGA) scale Timepoint: ; Change from baseline in DLQI total scoreTimepoint: ;Changes in Trozak histologic grading system for psoriasis based on biopsy reportTimepoint: ;Proportion of participants with TEAEs and SAEsTimepoint: | — |
Countries
India
Contacts
Public ContactDigambar Tornale
Sun Pharma Laboratories Limited
Outcome results
None listed