to study the effect and safety of two products in treatment of psoriasis.
- Conditions
- Clinically diagnosed localized, plaque psoriasis vulgaris or Palmoplanter psoriasis
- Registration Number
- CTRI/2012/09/003001
- Lead Sponsor
- Glenmark Pharmaceuticals Limited
- Brief Summary
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Written Informed consent obtained from interested subjects on Day 1. Patients with Clinically diagnosed localized, mild to moderate plaque psoriasis vulgaris or Palmoplanter psoriasis. The size of the lesion is measured and mentioned in the case report form. Subjects given medication as per randomization list allotted to each center. Follow up will be done on 7 and 14 days and disease improvement recorded on a 5 point LPSI scoring system. The subject’s observations on itching/pruritus, ease of application and cosmetic applicability noted at each visit. After stopping of medication the subject is treated as advised by investigator.
Global evaluation of therapeutic effects and subject assessment of pruritus to be noted at each visit.
In this trial treatment allocation to be in accordance with a predetermined randomization list. Medication to be given after obtaining consent and physical examination of the subject is done at Visit 1. The trial medications will be identical in appearance and supplied in identical tubes. Subjects instructed to apply the medication on the selected lesion of size 4cm2 to 10cm2 twice a day without occlusion with the duration of treatment to be 14 days. Supplied study drug is applied twice daily once in morning and other application in evening on the target lesion according to FTU (Finger Tip Unit) method. On the other lesions, patient can continue applying the emollients/moisturizer.
Efficacy parameters:
1. Investigator’s clinical assessment will be done to evaluate reduction of
a. erythema
b. scaling
c. thickness
These parameters will be evaluated according to LPSI score as follows:
Grade 0= None;
Grade 1= Slight;
Grade 2= Moderate;
Grade 3= Marked;
Grade 4= Marked
The therapeutic effects will be assessed on individual grading of erythema scaling and thickness.
2. Assessment of Pruritus:
Subject-reported Pruritus assessments rated on a 5-point Likert scale during Visit 1 (Baseline), Visit 2, and Visit 3 as follows:
0 – No Pruritus
1 – Minimal Pruritus
2 – Pruritus present but not requiring medications to control itching
3 – Pruritus present and requires medication to control itching
4 – Pruritus present not subsiding with medications
3. Global Evaluation will be assessed on a 4-point scale
1- Slight or Mild improvement (0% - 25%),
2 – Moderate improvement (25% - 50%),
3 – Marked improvement (50% to 75%) and
4– Almost clear/Clear (more than 75%)
(\* No signs of psoriasis, Post Inflammatory Hyperpigmentation may be present)
4. Subject’s observation
Subject’s observations on Cosmetic acceptability and Ease of application noted at Visit 2 & 3. Grading will be done as follows:
Grade 0 - Poor
Grade 1 - Average
Grade 2 - Good
Grade 3 - Very good.
5. Photographic assessment by the investigator
Photograph of lesion taken at Visit 1 (Baseline) and Visit 3 and clinical improvement will be assessed as follows
1- Slight or Mild improvement (0% - 25%),
2 – Moderate improvement (25% - 50%),
3 – Marked improvement (50% to 75%) and
4– Almost clear/Clear (more than 75%)
6. Serum Cortisol levels:
Measurement of serum Cortisol levels to assess extent of adrenal suppression after application of
medication at visit 1 and Visit 3. Blood samples taken early in the morning at 8 am. A random selection of 40% patients taken to assess HPA axis suppression.
7. Patient compliance:
Compliance of the patients will be noted by the investigator as average, good or excellent. Also a note made of the number of missed applications.
Additional Investigators:
| | | |
| --- | --- | --- |
|Name of Doctor
Address
Contact no.
|Dr Nimesh Mehta
N M Skin & Cosmetology Clinic, 101, Shree Uma HSG SOC, Near Starcity , Opp Asha Polyclinic, taical Wadi, Mahim 16
022 24328334
9820487714
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- 1.Subjects between 18 to 60 yrs ( treatment naïve patients or patients receiving treatments such as Corticosteroids, Methotrexate or PUVA should be given a wash out period of 10 days) 2.Clinically diagnosed localized, plaque psoriasis vulgaris or Palmoplanter psoriasis affecting maximum up to 10-20% of the total body surface area.
- The size of lesion selected is approximately 4 to 10 cm2 3.Subjects must provide written informed consent and comply to the protocol.
1.Subjects with psoriatic erythroderma, generalized pustular psoriasis 2.Pregnancy & Lactation 3.Concomitant tuberculosis 4.Syphilis 5.Uncontrolled Diabetes mellitus 6.Leukemia.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Investigator’s clinical assessment on LPSI score to evaluate reduction of erythema, scaling, thickness. 0day- 7days- 14 days 2.Assessment of Pruritus 0day- 7days- 14 days 3.Global Evaluation 0day- 7days- 14 days 4. Subjects observation 0day- 7days- 14 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Postgraduate Institute of Medical Education & Research
🇮🇳Chandigarh, CHANDIGARH, India
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
🇮🇳Thane, MAHARASHTRA, India
SAFDARJUNG HOSPITAL,
🇮🇳Delhi, DELHI, India
Skin Clinic
🇮🇳Pune, MAHARASHTRA, India
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College🇮🇳Mumbai, MAHARASHTRA, IndiaDr Rachita DuratPrincipal investigator9870390057rachitadhurat@yahoo.co.in