Health Condition 1: null- Subjects who suffers with cracked feet
Conditions
Interventions
Intervention1: Regen D 10: Epidermal growth factor (EGF)based gel with the concentration of 10ug per gram
Topical application twice a day and total duration 12 weeks
Control Intervention1: Placebo: Co
Sponsors
Bharat Biotech International Limited
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Healing of fissures 2. Assessment of HyperkeratosisTimepoint: Screening Day 0 Day 8±2 to 84±2 Visit 2 to 12 (2nd - 12th Week) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of pain at cracked areas 2. Assessment of incidence of adverse events, and subject compliance to the therapy 3. All the adverse events reported or observed by the subjects will be recorded with information about the severity, date of onset, duration regarding the study drug. 4. Comparative evaluation of efficacy of foot care cream/gel and the aesthetic attributesTimepoint: Screening Day 0 Day 8±2 to 84±2 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat biotech international Ltd
Outcome results
None listed