Observational Study to Evaluate Efficacy, Safety and Tolerability of Z-n-butylresorcinol in Patients with Melasma

An Open Label, Single Arm, Observational Study to Evaluate Efficacy, Safety and Tolerability of 4-n-butylresorcinol in Patients with Melasm

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/04/005697

Enrollment

Registered

2015-04-15

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- Melasma

Interventions

Intervention1: 4 n Butylresorcinol: Tyrosinase and TRP-1 inhibitor found useful in melasma and hyperpigmentation. Drug to be applied topically over the affected areas twice daily for a period of 8 wee

Eligibility

Inclusion criteria

Inclusion criteria: •Subjects with melasma who are either treatment naive or were not on any treatment for at-least 6 months •Subjects aged 18 and above years with melasma •Subjects with Epidermal type of melasma •Subjects with Fitzpatrick skin types III, IV and V •Subjects willing to apply sunscreen during the course of study •Subjects willing to return for all clinic visits and complete all study-related procedures

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Evaluate the efficacy of 4-n-butylresorcinol in reducing melasmaTimepoint: 4th week and 8th Week	—

Secondary

Measure	Time frame
Evaluate safety of 4-n-butylresorcinol based on the adverse effects as mentioned by the patient and evaluated by the investigator. Assess tolerability of 4-n-butylresorcinol by the investigators Timepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDrLokesh

Micro Labs Ltd

drmanjula@microlabs.in

Outcome results

None listed

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