The evaluation of efficacy of topical formulation of Henna (Lawsonia inermis) in prevention of contact dermatitis in patients using prosthesis
Phase 1
Recruiting
- Conditions
- Contact Dermatitis.Irritant contact dermatitis
- Registration Number
- IRCT20171229038126N1
- Lead Sponsor
- Kerman University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Lower extremity amputation
Lower extremity prothesis
Age of 12-70 years old
Exclusion Criteria
Any diagnosed dermatological disorder
Any diagnosed systemic disorder (i.e Diabetes)
Pregnancy or lactation
Allergy to Henna or hair coloring agents
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pruritus. Timepoint: 0, 1, 2, 3 months. Method of measurement: VAS (Visual Analogue Scale).
- Secondary Outcome Measures
Name Time Method Skin Moisture. Timepoint: Month :0-1-2-3. Method of measurement: KC Technology.;Skin erythema. Timepoint: Month:0-1-2-3. Method of measurement: KC Technology instrument.;Skin elasticity. Timepoint: Month:0-1-2-3. Method of measurement: KC Technology instrument.;Pain. Timepoint: Month;0-1-2-3. Method of measurement: visual Analogue Scale (VAS).;Quality of life. Timepoint: Month:0-1-2-3. Method of measurement: questionnaire.