A clinical trial to study the effects and tolerability topical 1 % menthol lotion in treatment of primary localized macular cutaneous amyloidosis
Not Applicable
- Conditions
- Health Condition 1: E854- Organ-limited amyloidosis
- Registration Number
- CTRI/2021/08/035574
- Lead Sponsor
- Pigmentary Disorder Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Total duration of illness more than six weeks
•Histopathologically confirmed cases of primary localized macular amyloidosis with congo red positivity
•Affected body surface area (BSA) <10 percent
Exclusion Criteria
•Pregnant/lactating females.
•Patient those with known coexisting psychiatry and chronic ailments viz. diabetes mellitus, malignancy, HIV or HBV.
•Lesion confined to face, axillae, and/or breasts.
•Unwillingness to participate in study.
•Known case of atopy, prior history of allergy to any topical medication.
•History of intake of systemic or topical antihistamine, non steroidal anti inflammatory, steroid or other immunosuppressive drugs for the last 4 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 100% improvement in itching and pigmentation <br/ ><br>Timepoint: before or till 24 weeks
- Secondary Outcome Measures
Name Time Method change in body surface areaTimepoint: at every 4 weeks upto 24 weeks;Change in degree of pigmentationTimepoint: every 4 weeks upto 24 weeks;Change in patternTimepoint: at every 4 weeks upto 24 weeks;change in site involvementTimepoint: at every 4 weeks upto 24 weeks;Histopathological changesTimepoint: before and after treatment completion;Improvement in itchingTimepoint: at every 4 weeks upto 24 weeks;Patient satisfactionTimepoint: at every 4 weeks upto 24 weeks