Double-blind, multicenter, prospective, comparative study to evaluate the efficacy and safety of 0.05% halobetasol propionate ointment and 0.05% clobetasol propionate ointment in subjects with chronic, localized plaque psoriasis

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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