MedPath

To study the effect of Atarax cream in human volunteers with itching.

Not Applicable
Completed
Registration Number
CTRI/2022/03/040739
Lead Sponsor
Dr Reddys Laboratories Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
32
Inclusion Criteria

1. Men and women between 18 and 55 years of age. (inclusive) diagnosed with chronic

pruritus with dryness

2. Participants with Chronic itch for more than 6 weeks (H/o Itch everyday )

3. Itch score on Visual analog scale (VAS) (mild to moderate ââ?¬â?? equal to or less than 7 on

VAS), on at least 1 site, ,

4. Cooperating to comply with protocol procedures and treatments, after being informed of

the need and duration of the examinations/treatments.

Exclusion Criteria

1.Pregnant women as confirmed by UPT

2. Females of childbearing potential who are unable or unwilling to use adequate

contraception or who are breast feeding

3. Participants with serious skin conditions like psoriasis, Uraemic pruritus

4. Participants Having known allergy to active ingredient or to any cosmetic.

5. Presence of any medical condition or disability that could interfere with study

6. Participants with Any systemic/topical treatment for itching for considerable duration.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Patient questionnaire response will be taken, based on 10-point VAS. <br/ ><br>2. Time point at which they need to reapply (Itch free period) will be recorded.Timepoint: Baseline, 3 mins, <br/ ><br>5 mins, 10 mins, 15 mins, 30 mins, 60 mins, 90 mins, 2 hrs, 4 hrs, 6 hrs, 8 hrs post application of test product.
Secondary Outcome Measures
NameTimeMethod
ilTimepoint: Nil
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