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A clinical trial to study the effects and tolerability topical 1 % menthol lotion in treatment of primary localized macular cutaneous amyloidosis

Efficacy and tolerability of topical 1 % menthol lotion in treatment of primary localized macular cutaneous amyloidosis: A randomized triple blinded placebo controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035574
Enrollment
32
Registered
2021-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E854- Organ-limited amyloidosis

Interventions

Intervention1: menthol lotion: 1% menthol (1 gm/100ml) lotion, 0.5 ml of menthol lotion for every 1% body surface area, in two divided dose for 24 weeks or absence of pigmentation and itching, whichev

Sponsors

Pigmentary Disorder Society
Lead Sponsor
Dr Kiran Preet Malhotra
Collaborator
Dr Parul Verma
Collaborator
Dr Suaib Luqman
Collaborator
Dr Usha Chandra
Collaborator

Eligibility

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
100% improvement in itching and pigmentation Timepoint: before or till 24 weeks

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Swastika Suvirya

King George Medical University, Lucknow

swastika.p@gmail.com9918991945

Outcome results

None listed

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