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Curcuma Xanthorriza Roxb. 10% Cream for Melasma

NCT06153134 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-12-01

No results posted yet for this study

Summary

Melasma is an acquired hyperpigmentation disorder with a multifactorial etiology and complex pathogenesis that can significantly diminish the quality of life for affected patients. As of now, melasma therapy remains challenging due to its high recurrence rate and the common occurrence of treatment-related side effects. The use of depigmentation agents is a crucial component in managing melasma. Hydroquinone stands as the first-line depigmentation agent for melasma; however, its use often leads to adverse effects. Therefore, alternative depigmentation agents are needed. Curcuma xanthorriza Roxb., a native plant of Indonesia, operates by inhibiting the tyrosinase enzyme, reducing MITF transcription, and inhibiting α-MSH. Despite these potential benefits, Curcuma xanthorriza Roxb. has not been utilized as a depigmentation agent. Research on the effectiveness of Curcuma xanthorriza Roxb. as a depigmentation agent in melasma treatment has not been conducted. Therefore, it is essential to conduct research to determine the effectiveness of a 10% Curcuma xanthorrhiza Roxb. cream in reducing MASI scores and enhancing skin brightness in epidermal-type melasma.

Conditions

  • Melasma

Interventions

DRUG

10% Curcuma xanthorriza Roxb.

Patients in experimental arms will receive 10% Curcuma xanthorriza Roxb. cream for 2 months

DRUG

2% Kojic Acid

Patients in experimental arms will receive 2% Kojic Acid cream for 2 months

Sponsors & Collaborators

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Reti Hindritiani, M.D. · Faculty of Medicine Universitas Padjadjaran Bandung

  • Diah Puspitosari, M.D. · Faculty of Medicine Universitas Padjadjaran Bandung

  • Fathia Rianty, M.D. · Faculty of Medicine Universitas Padjadjaran Bandung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2024-02-22
Completion
2024-05-22

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153134 on ClinicalTrials.gov