MelasmaEarly Phase 1NCT06153134
Curcuma Xanthorriza Roxb. 10% Cream for Melasma
A Early Phase 1 study testing 10% Curcuma xanthorriza Roxb. and 2% Kojic Acid in people with Melasma, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- 10% Curcuma xanthorriza Roxb. and 2% Kojic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndonesia
- Study dates
- 22 Dec 2023to 22 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Hasan Sadikin General Hospital
Bandung, West Java, 40161
Fathia Rianty
About this study
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.
Read the 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.
- Conditions
- Melasma
- Being tested
- 10% Curcuma xanthorriza Roxb., 2% Kojic Acid
- Keywords
- Melasma, MASI, Specthrophotometry, Curcuma xanthorriza, Curcuma, Depigmenting agent
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Curcuma xanthorriza Roxb.Drug
Patients in experimental arms will receive 10% Curcuma xanthorriza Roxb. cream for 2 months
2% Kojic AcidDrug
Patients in experimental arms will receive 2% Kojic Acid cream for 2 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 2% Kojic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 56 days
Secondary outcomes (1)
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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start22 Dec 2023 (estimated)
- Primary completion22 Feb 2024 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reti Hindritiani, M.D., Study chair, Faculty of Medicine Universitas Padjadjaran BandungDiah Puspitosari, M.D., Study director, Faculty of Medicine Universitas Padjadjaran BandungFathia Rianty, M.D., Study director, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153134
- Sponsor's protocol ID
- DV-202311.01
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06153134
- Acronym / sponsor ID
- DV-202311.01
- Conditions
- Melasma
- Keywords
- Melasma, MASI, Specthrophotometry, Curcuma xanthorriza, Curcuma, Depigmenting agent
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 22 Dec 2023 (estimated)
- Primary completion
- 22 Feb 2024 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcuma xanthorriza Roxb. | Active comparator | Drug: 10% 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. |
| Kojic acid | Active comparator | Drug: 2% Kojic AcidFifteen 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Curcuma xanthorriza Roxb.Patients in experimental arms will receive 10% Curcuma xanthorriza Roxb. cream for 2 months | Drug | Curcuma xanthorriza Roxb. |
| 2% Kojic AcidPatients in experimental arms will receive 2% Kojic Acid cream for 2 months | Drug | Kojic acid |
Primary outcome
Modified Melasma Area and Severity Index (MASI) score
Time frame: 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
Time frame: 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).
1 secondary outcome
Side Effects
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reti Hindritiani, M.D. study chair
Faculty of Medicine Universitas Padjadjaran Bandung
Diah Puspitosari, M.D. study director
Faculty of Medicine Universitas Padjadjaran Bandung
Fathia Rianty, M.D. study director
Faculty of Medicine Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 10% Curcuma xanthorriza Roxb. and 2% Kojic Acid in people with Melasma, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fathia Rianty, M.D. (+6281225955478, fathrianty@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Melasma Area and Severity Index (MASI) score (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.