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A study to compare the effect of two creams (cysteamine 5% cream and a triple combination cream composed of fluocinolone, tretinoin and hydroquinone) in the treatment of a pigmentation disorder of face called as melasma

Effectiveness, safety and tolerability of cysteamine 5% cream vs triple combination cream in epidermal melasma : an open label randomised controlled clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108268
Enrollment
78
Registered
2026-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Cysteamine 5% cream: To be applied once daily at bedtime and wash away after 15 minutes Control Intervention1: Triple combination cream: To be applied once daily at bedtime

Sponsors

KPC Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients more than 18 yrs age with a clinical diagnosis of melasma

Exclusion criteria

Exclusion criteria: 1. Received topical (2 weeks) or systemic treatment (4 weeks) 2. Received previous treatment topical or systemic in the last 1 month 3. Any history of hypersensitivity to the study medications 4. Pregnancy and lactating females 5. Immunocompromised or immunosuppressed patients 6. Patients with potential interaction with the study medications

Design outcomes

Primary

MeasureTime frame
Reduction in modified melasma area and severity indexTimepoint: Week 0, week 4, week 8, week 12

Secondary

MeasureTime frame
Improvement in quality of life measured by dermatology life quality indexTimepoint: Week 0, week 4, week 8, week 12

Countries

India

Contacts

Public ContactDr Sambit Chatterjee

KPC Medical College and Hospital

sambitchat@yahoo.co.in9748244633

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026