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The evaluation of efficacy of topical formulation of Henna (Lawsonia inermis) in prevention of contact dermatitis in patients using prosthesis

The evaluation of efficacy of topical formulation of Henna (Lawsonia inermis) in prevention of contact dermatitis in patients using prosthesis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171229038126N1
Enrollment
72
Registered
2018-04-29
Start date
2018-05-20
Completion date
Unknown
Last updated
2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Dermatitis. Irritant contact dermatitis

Interventions

Intervention 1: Henna extract cream 1%, 3 times/day for 3 months. Intervention 2: Control group: placebo cream , 3 times/day for 3 months.

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 70 Years

Inclusion criteria

Inclusion criteria: Lower extremity amputation Lower extremity prothesis Age of 12-70 years old

Exclusion criteria

Exclusion criteria: Any diagnosed dermatological disorder Any diagnosed systemic disorder (i.e Diabetes) Pregnancy or lactation Allergy to Henna or hair coloring agents

Design outcomes

Primary

MeasureTime frame
Pruritus. Timepoint: 0, 1, 2, 3 months. Method of measurement: VAS (Visual Analogue Scale).

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Mehrzad Mehrabani

Kerman University of Medical Sciences

mzmehrbani@yahoo.com+98 34 3312 2023

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026