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This is an observational study to determine the efficacy and safety of vitamin-c in melasma patients

Post marketing surveillance for evaluation of efficacy and safety of vitamin c 15% w/w in melasma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001160
Enrollment
24
Registered
2010-08-03
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- Facial Melasma

Interventions

Intervention1: Vitamin C 15 % w/w: To apply 7 drops on the face once at morning time Control Intervention1: NIL: NIL

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Written informed consent 2.Subjects of either sex 18 years and above 3.Subjects with diagnosis of Facial Melasma 4.In the opinion of the investigator, able to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1.Subjects hypersensitive to any of the component of the investigational product 2.Judged by Investigator to be inappropriate as subjects

Design outcomes

Primary

MeasureTime frame
Improvement in Melasma Area and Severity IndexTimepoint: From baseline to 4, 8, 12 and 16 week of treatment period

Secondary

MeasureTime frame
1.Results of patients self assessmentTimepoint: From baseline to 4,8,12 and 16 weeks;2.Photographic improvementTimepoint: From baseline to 16 weeks;3.Skin tolerability will be notedTimepoint: From baseline to 16 weeks;4. Incidence and nature of adverse eventsTimepoint: From baseline to 16 weeks;5. Incidence of drug related adverse reactionsTimepoint: From baseline to 16 weeks

Countries

India

Contacts

Public ContactDr K S Ram
jgogtay@cipla.com022-23025412

Outcome results

None listed

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