Global evaluation of therapeutic effects and subject assessment of pruritus to be noted at each visit.

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%)