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Usefulness and safety of Metformin and Canthexâ?¢ in patients with thickening and darkening of skin over neck

Effectiveness and safety of Metformin and Canthexâ?¢ in patients with Acanthosis nigricans: a randomized, double blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007880
Enrollment
44
Registered
2017-02-15
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: null- Patients of age 18 years or more of either sex presenting with acanthosis nigricans

Interventions

Intervention1: Canthexâ?¢: Capsule containing fixed dose combination of alpha lipoic acid 200 mg, biotin 5 mg, calcium pantothenate 200 mcg and zinc sulphate 25 mg, each capsule to be taken twice dail

Sponsors

Department of Dermatology Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients aged more than 18 years of either sex presenting with Acanthosis Nigricans

Exclusion criteria

Exclusion criteria: Pregnant and lactating women Patients with Renal and/or hepatic compromise Patients not consenting to participate in the study

Design outcomes

Primary

MeasureTime frame
A.Clinical effectiveness of Canthex versus Metformin by 1.Severity of neck lesions of Acanthosis nigricans 2.Neck texture of Acanthosis nigricans 3.Physician global assessment score B.Safety of two treatment arms 1. By checklist for adverse events 2. CDSCO ADR reporting form 3. Laboratory investigationsTimepoint: Baseline and at 4, 8 and 12 weeks after randomization

Secondary

MeasureTime frame
A.Improvement in Insulin resistance with Metformin versus Canthexâ?¢ by 1.Body Mass Index 2.Waist Circumference 3.Fasting Blood Sugar 4.Fasting Insulin level 5.Fasting serum lipids B.Quality of life in the two treatment arms by Dermatology Life Quality Index (DLQI)Timepoint: Baseline and at 4, 8 and 12 weeks after randomization

Countries

India

Contacts

Public ContactDr Adrija Datta

Department of Dermatology, Medical College, Kolkata, West Bengal

drdasnilay@gmail.com9433394148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 3, 2026