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Curcuma Xanthorriza Roxb. 10% Cream for Melasma

NCT ID: NCT06153134

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-22

Study Completion Date

2024-05-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melasma

Keywords

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Melasma MASI Specthrophotometry Curcuma xanthorriza Curcuma Depigmenting agent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

10% Curcuma xanthorriza Roxb.

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

2% Kojic Acid

Intervention Type DRUG

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

Interventions

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10% Curcuma xanthorriza Roxb.

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

Intervention Type DRUG

2% Kojic Acid

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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitas Padjadjaran

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reti Hindritiani, M.D.

Role: STUDY_CHAIR

Faculty of Medicine Universitas Padjadjaran Bandung

Diah Puspitosari, M.D.

Role: STUDY_DIRECTOR

Faculty of Medicine Universitas Padjadjaran Bandung

Fathia Rianty, M.D.

Role: STUDY_DIRECTOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

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Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Fathia Rianty, M.D.

Role: CONTACT

Phone: +6281225955478

Email: [email protected]

Reti Hindritiani, M.D., PhD

Role: CONTACT

Phone: +628156022505

Email: [email protected]

Facility Contacts

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Fathia Rianty

Role: primary

Other Identifiers

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DV-202311.01

Identifier Type: -

Identifier Source: org_study_id