Curcuma Xanthorriza Roxb. 10% Cream for Melasma

Sponsor

Universitas Padjadjaran (Other)

Overall Status

Recruiting

CT.gov ID

NCT06153134

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: 10% Curcuma xanthorriza Roxb. Drug: 2% Kojic Acid	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 22, 2023

Anticipated Primary Completion Date :

Feb 22, 2024

Anticipated Study Completion Date :

May 22, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Modified Melasma Area and Severity Index (MASI) score [56 days]
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).
Skin Brightness [56 days]
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).

Secondary Outcome Measures

Side Effects [56 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasan Sadikin General Hospital	Bandung	West Java	Indonesia	40161

Sponsors and Collaborators

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