Curcuma Xanthorriza Roxb. 10% Cream for Melasma

NCT06153134 | Unknown Early Phase 1 DMC

• 1 other identifier: DV-202311.01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

Melasma; MASI; Specthrophotometry; Curcuma xanthorriza; Curcuma; Depigmenting agent

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Side Effects

  56 days

Study Arms (2)

Curcuma xanthorriza Roxb.

ACTIVE COMPARATOR

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.

Kojic acid

ACTIVE COMPARATOR

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

Interventions

10% Curcuma xanthorriza Roxb. DRUG

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

Curcuma xanthorriza Roxb.

2% Kojic Acid DRUG

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

Kojic acid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

kojic acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Reti Hindritiani, M.D.

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY CHAIR

• Diah Puspitosari, M.D.

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

• Fathia Rianty, M.D.

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

Central Study Contacts

Fathia Rianty, M.D.

CONTACT

+6281225955478; fathrianty@gmail.com

Reti Hindritiani, M.D., PhD

CONTACT

+628156022505; r_hindritiani@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 22, 2023
• Primary Completion: February 22, 2024
• Study Completion: May 22, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

ID (1)