Curcuma Xanthorriza Roxb. 10% Cream for Melasma

Effectiveness of Curcuma Xanthorriza Roxb. 10% Cream in Reducing Melasma Area and Severity Index (MASI) Scores and Improvement of Skin Brightness in Epidermal Type Melasma

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.

Study Overview

• Status: Recruiting
• Conditions: Melasma
• Intervention / Treatment: Drug: 10% Curcuma xanthorriza Roxb.; Drug: 2% Kojic Acid

Detailed Description

Curcuma xanthorrhiza Roxb., known locally as temulawak in Indonesia or koneng gede in Sundanese, is a member of the Zingiberaceae family and is native to Indonesia. Previous research related to Curcuma xanthorriza Roxb. and its impact on melanin synthesis was conducted using mushroom tyrosinase by Batubara et al. The study found that methanol extract of Curcuma xanthorriza Roxb. could decrease tyrosinase enzyme activity with an inhibition concentration 50% (IC50) of 0.27 mg/mL.

Research conducted by Lee et al. on curcumin from another Curcuma species, C. longa or turmeric, demonstrated that curcumin reduced melanin quantity, tyrosinase enzyme activity, and micropthalmia-associated transcription factor (MITF) protein. In an in-silico study, Mustarichie et al. reported that the three active compounds in Curcuma xanthorriza Roxb. could inhibit both tyrosinase enzyme and α-melanin stimulating hormone (α-MSH). Xanthorrizol exhibited the most effective interaction with the tyrosinase enzyme, while demethoxycurcumin showed the most effective interaction with α-MSH.

Up to this point, there has been no research on the effectiveness of 10% Curcuma xanthorriza Roxb. cream in treating melasma. Therefore, the researchers are motivated to investigate the efficacy of 10% Curcuma xanthorriza Roxb. cream as a depigmentation agent, based on the assessment of MASI scores and skin brightness levels in patients with epidermal-type melasma using split-face therapy.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Fathia Rianty, M.D.; Phone Number: +6281225955478; Email: fathrianty@gmail.com
• Study Contact Backup: Name: Reti Hindritiani, M.D., PhD; Phone Number: +628156022505; Email: r_hindritiani@yahoo.com

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40161
      • Recruiting
      • Hasan Sadikin General Hospital
      • Contact: Fathia Rianty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Females and males diagnosed with epidermal-type melasma clinically and through Wood's lamp examination.
• Study subjects exhibit melasma lesions on both sides of the face.

Exclusion Criteria:

• History of hypersensitivity to Curcuma xanthorriza Roxb. or kojic acid based on anamnesis.
• Pregnant and breastfeeding women.
• Patients using hormonal contraceptive drugs in the last 3 months.
• Patients using topical medications (depigmentation agents, tretinoin, or corticosteroids) in the skin area to be tested in the last 2 weeks.
• Patients using systemic corticosteroids in the last 1 month.
• Patients undergoing laser therapy, microdermabrasion, chemical peels, and other aesthetic procedures in the skin area to be tested in the last 1 month.
• Patients experiencing inflammation on the facial skin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Curcuma xanthorriza Roxb.; Fifteen patients will apply 10% Curcuma xanthorriza Roxb. cream topically at the half of the face, once daily in night, for 2 months. Along with study drug or positive control, patients will receive standard uniform sunscreen and face wash.	Drug: 10% Curcuma xanthorriza Roxb.; Patients in experimental arms will receive 10% Curcuma xanthorriza Roxb. cream for 2 months
Active Comparator: Kojic acid; Fifteen patients will apply 2% kojic acid cream topically at the half of the face, once daily in night, for 2 months. Along with study drug or positive control, patients will receive standard uniform sunscreen and face wash.	Drug: 2% Kojic Acid; Patients in experimental arms will receive 2% Kojic Acid cream for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Melasma Area and Severity Index (MASI) score	Measurement scale for subjectively assessing the severity of melasma. There are three variables used to gauge the severity of melasma, namely darkness (D), homogeneity (H), and involved area (A).	56 days
Skin Brightness	The brightness level of the skin is measured using a spectrophotometer. Skin brightness is assessed based on the L* value, which ranges from total darkness (L* = 0) to total whiteness (L* = 100).	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects	Undesirable reactions that may occur on the skin following therapy with 10% Curcuma xanthorriza Roxb. cream or 2% kojic acid cream include sensations such as itching, a burning sensation, erythema, erythematous papules, edema, blistering, urticaria, or post-inflammatory hyperpigmentation.	56 days

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Study Chair: Reti Hindritiani, M.D., Faculty of Medicine Universitas Padjadjaran Bandung; Study Director: Diah Puspitosari, M.D., Faculty of Medicine Universitas Padjadjaran Bandung; Study Director: Fathia Rianty, M.D., Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

Study Major Dates

• Study Start (Estimated): December 22, 2023
• Primary Completion (Estimated): February 22, 2024
• Study Completion (Estimated): May 22, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Melasma; Curcuma; MASI; Specthrophotometry; Curcuma xanthorriza; Depigmenting agent
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Kojic acid
• Other Study ID Numbers: DV-202311.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No