Melasma Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | May 22, 2024 |
Est. primary completion date | February 22, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Hasan Sadikin General Hospital | Bandung | West Java |
Lead Sponsor | Collaborator |
---|---|
Universitas Padjadjaran |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 |
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