Phase-II study to evaluate safety and effectivity ofREGEN-D® 10 in treatment of cracked feet
- Conditions
- Health Condition 1: null- Subjects who suffers with cracked feet
- Registration Number
- CTRI/2017/03/008000
- Lead Sponsor
- Bharat Biotech International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
i. Healthy subjects as established by medical history and
clinical examination before entering the study.
ii. 18 to 60 years of age either male or female with
cracks/fissures on feet.
iii. Subjects who have fissures of depth and/or width of up
to 1cm.
iv. Ability and willingness to provide informed consent.
v. Subjects who intend to remain in the area and agree for
follow up.
i. Any feet wound or abrasion
ii. Subjects having peripheral vascular disease such as
psoriasis, eczema, ichthyosis vulgaris.
iii. Subjects having significant Cellulites or Abscess near or
on the heel.
iv. Subjects who have fissures of depth and/or width of
more than 1cm.v. Subjects having any skin growth (mole, wart, etc.) at
application site.
vi. Known diabetes mellitus, hypertension and thyroid
disorder.
vii. Pre-existing immunocompromised disease.
viii. Use of any topical steroids or moisturizers on the feet
previous 2 weeks.
ix. Known hypersensitivity to any components of the study
medication.
x. Subjects having erysipelas and vasculitis.
xi. Subjects who had participated in a clinical study with a
moisturizing product within the previous 4 weeks.
xii. Concurrent participation in another clinical trial
throughout the entire timeframe of this study.
xiii. Subjectsâ?? not able, available or willing to accept active
follow-up by the study staff.
xiv. Any medical condition in the subject that, in the
judgment of the investigator, would interfere with or
serves as a contraindication to protocol adherencea
subjectsâ?? ability to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Healing of fissures <br/ ><br>2. Assessment of HyperkeratosisTimepoint: Screening <br/ ><br>Day 0 <br/ ><br>Day 8±2 to <br/ ><br>84±2 <br/ ><br>Visit 2 to 12 <br/ ><br>(2nd - 12th <br/ ><br>Week)
- Secondary Outcome Measures
Name Time Method 1. Assessment of pain at cracked areas 2. Assessment of incidence of adverse events, and subject <br/ ><br>compliance to the therapy 3. All the adverse events reported or observed by the subjects <br/ ><br>will be recorded with information about the severity, date <br/ ><br>of onset, duration regarding the study drug. 4. Comparative evaluation of efficacy of foot care cream/gel <br/ ><br>and the aesthetic attributesTimepoint: Screening <br/ ><br>Day 0 <br/ ><br>Day 8±2 to <br/ ><br>84±2 <br/ ><br>