Health Condition 1: L409- Psoriasis, unspecified
Conditions
Interventions
Intervention1: Boswell cream: One-half of the body will be randomly assigned to treatment with Boswell cream.
The cream will be applied to the affected area (lesion) twice a day for 12 consecutive wee
Sponsors
Rajalakshmi Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients belonging to either gender between 18-60 years. 2. Patients with a clinical diagnosis of stable plaque psoriasis for at least 6 months duration. 3. Patients with a psoriasis involvement less than 10% of total body surface. 4. Patients with category “mild or moderate ? on Investigator Global Assessment (IGA) scale. 6. Patients with treatment area amenable to topical treatment and easy clinical assessment. 7. Patients who have no clinically significant abnormalities during physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous system) and vital sign assessments. 8.Patients willing to give written informed consent and adhere to all the requirements of this protocol.
Exclusion criteria
Exclusion criteria: 1.Patients with known hypersensitivity or allergic skin. 2. Pregnant or lactating females. 3. Patients currently having non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis or a drug induced form of psoriasis. 4. Patients with systemic treatment with immunosuppressive drugs or corticosteroids within 4 weeks prior to enrollment. Note: Inhaled or intranasal steroids for asthma or rhinitis may be used 5. Patients with systemic treatment with retinoids within 8 weeks prior to enrollment. 6. Patients with topical treatment with immune-modulators or corticosteroids within 4 weeks prior to enrollment. 7. Patients with phototherapy treatment within 4 weeks prior to enrollment. 8. Patients with other topical therapy on the treatment area within 1 week prior to enrollment. 9. Patients requiring use of anti-histamine treatment during the study. 10. Patients with clinical infection on the treatment area. 11.Patients with presence or history of cancer including skin cancer. 12. Patients with evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. 13. Patients with presence or history of an immunocompromised disease. 14. Patients with intense sun exposure during the study. 15. Patients known or suspected of not being able to comply with the trial protocol (e.g. alcoholism, drug dependency, or psychotic state). 16. Patients with history of severe cardiac, pulmonary, hepatic, renal, neurologic disease or mental illness. 17. Patients with any medical condition or use of any medications that, in the opinion of the Principal Investigator, should preclude participation. 18. Patients who have participated in a clinical study in the past 30 days or current participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global response to treatment for the target lesion based on TPSSTimepoint: Visit 01 (Day 0): Screening/Enrolment Visit, Visit 02 (Day 28 ± 2): Assessment Visit, Visit 03 (Day 56 ± 3): Assessment Visit,Visit 04 (Day 84 ± 3): End of Treatment Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 12 & Tolerability of treatmentTimepoint: Visit 01 (Day 0): Screening/Enrolment Visit, Visit 02 (Day 28 ± 2): Assessment Visit, Visit 03 (Day 56 ± 3): Assessment Visit,Visit 04 (Day 84 ± 3): End of Treatment Visit | — |
Countries
India
Contacts
Public ContactDr Suman G
Rajalakshmi Hospital & Research Centre
Outcome results
None listed