To study the effect of Atarax cream in human volunteers with itching.
- 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
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.
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
Name Time Method 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
Name Time Method ilTimepoint: Nil