Clinical trial NCT06153134: Curcuma Xanthorriza Roxb. 10% Cream for Melasma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Melasma
Keywords: Melasma
MASI
Specthrophotometry
Curcuma xanthorriza
Curcuma
Depigmenting agent
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Melasma Area and Severity Index (MASI) score
timeFrame: 56 days
measure: Skin Brightness
timeFrame: 56 days
Secondary outcomes:
measure: Side Effects
timeFrame: 56 days
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Reti Hindritiani, M.D.
role: STUDY_CHAIR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Diah Puspitosari, M.D.
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Fathia Rianty, M.D.
role: STUDY_DIRECTOR
References: