MelasmaPhase 2NCT06957834
Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study
A Phase 2 study testing Eflornithine hydrochloride cream and Hydroquinone cream in people with Melasma, run by National Skin Centre at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Melasma
- What is being tested?
- Eflornithine hydrochloride cream and Hydroquinone cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Jun 2023to 11 Jul 2024
- Phase
- Phase 2
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of melasma
- Fitzpatrick Type III or IV
- Able to provide informed consent
Who cannot join
- Pregnant or lactating patients
- Patients with difficulty adhering to regular topical treatments
- Patients with known contact allergies to any of the ingredients in the topical medications used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Double-blinded Split-face Controlled Study to Evaluate the Effectiveness of Eflornithine Hydrochloride Cream Compared to Topical Hydroquinone 2% Cream for the Treatment of Melasma.
The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. The main questions it aims to answer are:
- Does Eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to Hydroquinone cream?
- What side effects might patients get while using Eflornithine hydrochloride cream?
Read more
Participants will:
- Apply both Eflornithine hydrochloride and Hydroquinone creams on separate halves of their faces every day for 3 months.
- Visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.
- Conditions
- Melasma
- Being tested
- Eflornithine hydrochloride cream, Hydroquinone cream
- Keywords
- Melasma, Dermatology, Eflornithine
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eflornithine hydrochloride creamDrug
Eflornithine hydrochloride cream at 11.5% applied twice daily
Hydroquinone creamDrug
Hydroquinone 2% cream, applied twice daily
| Study group | Role | What they receive |
|---|---|---|
| Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face | Active comparator | Not described Receives: Drug: Eflornithine hydrochloride cream; Drug: Hydroquinone cream |
| Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face | Active comparator | Not described Receives: Drug: Eflornithine hydrochloride cream; Drug: Hydroquinone cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Melasma Area and Severity Index (mMASI)
Measured: At 8 weeks and 12 weeks
Mexameter melanin score
Mexameter device (Courage + Khazaka Electronic GmbH, Germany)
Measured: At 8 and 12 weeks
Secondary outcomes (3)
Mexameter erythema score
Mexameter device (Courage + Khazaka Electronic GmbH, Germany)
Measured: At 8 and 12 weeks
Patient Satisfaction Score
For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe)
Measured: At 8 and 12 weeks
Physician Global Assessment
For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe)
Measured: At 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2025
- Study start6 Jun 2023
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blinded, split-face study. Both treatments (Eflornithine hydrochloride, and Hydroquinone) will be applied simultaneously: one on the left side of the face and the other on the right side. Treatment allocation to facial sides will be randomized, and participants blinded (both treatments with similar packaging, look and consistency). Outcomes will be assessed on each side of the face by a blinded evaluator.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Skin Centre
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Steven Thng Tien Guan, National Skin Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957834
- Sponsor's protocol ID
- 2019/00399
- Other IDs
- 2019
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 5 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in publication
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double-blinded Split-face Controlled Study to Evaluate the Effectiveness of Eflornithine Hydrochloride Cream Compared to Topical Hydroquinone 2% Cream for the Treatment of Melasma.
- ClinicalTrials.gov ID
- NCT06957834
- Acronym / sponsor ID
- 2019/00399
- Conditions
- Melasma
- Keywords
- Melasma, Dermatology, Eflornithine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Skin CentreResearch network
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 5 May 2025 (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.
The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. The main questions it aims to answer are:
- Does Eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to Hydroquinone cream?
- What side effects might patients get while using Eflornithine hydrochloride cream?
Participants will:
- Apply both Eflornithine hydrochloride and Hydroquinone creams on separate halves of their faces every day for 3 months.
- Visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blinded, split-face study. Both treatments (Eflornithine hydrochloride, and Hydroquinone) will be applied simultaneously: one on the left side of the face and the other on the right side. Treatment allocation to facial sides will be randomized, and participants blinded (both treatments with similar packaging, look and consistency). Outcomes will be assessed on each side of the face by a blinded evaluator.
| Arm | Type | Receives |
|---|---|---|
| Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face | Active comparator | Drug: Eflornithine hydrochloride cream, Drug: Hydroquinone cream |
| Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face | Active comparator | Drug: Eflornithine hydrochloride cream, Drug: Hydroquinone cream |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of melasma
- Fitzpatrick Type III or IV
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Pregnant or lactating patients
- Patients with difficulty adhering to regular topical treatments
- Patients with known contact allergies to any of the ingredients in the topical medications used in the study
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 |
|---|---|---|
| Eflornithine hydrochloride creamEflornithine hydrochloride cream at 11.5% applied twice daily | Drug | Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face, Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face |
| Hydroquinone creamHydroquinone 2% cream, applied twice daily | Drug | Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face, Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face |
Primary outcome
Modified Melasma Area and Severity Index (mMASI)
Time frame: At 8 weeks and 12 weeks
Mexameter melanin score
Time frame: At 8 and 12 weeks
Mexameter device (Courage + Khazaka Electronic GmbH, Germany)
3 secondary outcomes
Mexameter erythema score
Time frame: At 8 and 12 weeks
Patient Satisfaction Score
Time frame: At 8 and 12 weeks
Physician Global Assessment
Time frame: At 8 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eflornithine hydrochloride cream and Hydroquinone cream in people with Melasma, run by National Skin Centre at 1 site in Singapore.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 May 2025. 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 Singapore. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Melasma Area and Severity Index (mMASI) (time frame: At 8 weeks and 12 weeks). 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 5 May 2025.