Clinical trial

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

Name
DV-202311.01
Description
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.
Trial arms
Trial start
2023-12-22
Estimated PCD
2024-02-22
Trial end
2024-05-22
Status
Recruiting
Phase
Early phase I
Treatment
10% Curcuma xanthorriza Roxb.
Patients in experimental arms will receive 10% Curcuma xanthorriza Roxb. cream for 2 months
Arms:
Curcuma xanthorriza Roxb.
2% Kojic Acid
Patients in experimental arms will receive 2% Kojic Acid cream for 2 months
Arms:
Kojic acid
Size
15
Primary endpoint
Modified Melasma Area and Severity Index (MASI) score
56 days
Skin Brightness
56 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}
Updated at
2023-12-01

1 organization

2 products

1 indication

Indication
Melasma