MelasmaPhase 2NCT07876323
Randomized Split-Face Controlled Study to Evaluate the Effectiveness of Topical Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% as Compared to Topical Tretinoin 0.05% + Hydroquinone 4% + Fluocinolone 0.01% for the Treatment of Melasma
A Phase 2 study testing Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream and Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream in people with Melasma and Melasma (Facial Melasma), run by National Skin Centre at 1 site in Singapore.
Trial summary
The purpose of this study is to find out whether a new combination cream containing eflornithine, hydroquinone, and fluocinolone works better and causes fewer side effects than Tri-Luma® (tretinoin, hydroquinone, and fluocinolone), a commonly used treatment for melasma. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Melasma, Melasma (Facial Melasma)
- What is being tested?
- Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream and Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults aged 25 to 75 years diagnosed with melasma, Fitzpatrick skin phototypes III or IV, provision of written informed consent, and similar melasma severity scale scores on both sides of the face at baseline.
Who cannot join
- pregnant or lactating patients, patients known to be uncooperative, and patients with known contact allergy to any of the ingredients in the topical medications (such as eflornithine hydrochloride, hydroquinone, fluocinolone acetonide, tretinoin, methylparaben, or polyethylene glycol).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out whether a new combination cream containing eflornithine, hydroquinone, and fluocinolone works better and causes fewer side effects than Tri-Luma® (tretinoin, hydroquinone, and fluocinolone), a commonly used treatment for melasma.
The main question is whether replacing tretinoin in Tri-Luma® with eflornithine leads to greater improvement in melasma and less skin irritation over a 12-week period.
- Conditions
- Melasma, Melasma (Facial Melasma)
- Being tested
- Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream, Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream
- Keywords
- melasma, 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 9.58% + Hydroquinone 4% + Fluocinolone 0.01% creamDrug
Each subject receives both interventions ( eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream) simultaneously, one on each randomized side of the face.
Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% creamDrug
Each subject receives both interventions ( eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream) simultaneously, one on each randomized side of the face.
| Study group | Role | What they receive |
|---|---|---|
| Split face study comparing the effectiveness and safety of two different topical formulations | Other | Every subject receives both interventions at the same time, just on different randomized sides of the face. Each subject will be randomized to apply eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream to one side of face and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream on the other side. The study creams will be packaged in identical containers so that the identity of the cream is not known. Subjects and outcomes assessors were blinded to the treatment allocations. Receives: Drug: Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream; Drug: Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% 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) score
Calculated by assessing the area of involvement and the darkness of melasma across four facial regions. It yields a total score from 0 (clear) to 24 (severe)
Measured: From enrolment to the end of treatment at 12 weeks
Change from baseline in Melanin Index (M) measured using the SkinColorCatch®
Melanin Index (M) will be measured objectively using the SkinColorCatch® colorimeter on each side of the face. The change in Melanin Index from baseline to month 3 will be calculated for each treatment side. The change from baseline will be compared between the side treated with eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% and the side treated with tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01%. Lower Melanin Index values indicate lower skin pigmentation.
Measured: From enrolment to the end of treatment at 12 weeks
Physician Global Assessment
Obtained through a clinician's visual evaluation of the patient's facial hyperpigmentation, grading the overall severity on a standardized scale
Measured: From enrolment to the end of treatment at 12 weeks
Patient Global Assessment
Obtained through patient's visual evaluation of their facial hyperpigmentation, grading the overall severity on a standardized scale
Measured: From enrolment to the end of treatment at 12 weeks
Secondary outcomes (1)
Adverse events (AEs) and serious adverse events (SAEs)
AE include contact dermatitis, SAE include severe allergy reactions with contact dermatitis with secondary spread and lymph node enlargement, ochronosis and skin atrophy.
Measured: From enrolment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Split face study. Each subject will be randomized to apply eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream to one side of face and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream on the other side. The study creams will be packaged in identical containers so that the identity of the cream is not known.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Skin Centre
- Sponsor type
- Research network
- Collaborators
- Agency for Science, Technology and Research (A*STAR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876323
- Sponsor's protocol ID
- 2021/01169
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Split-Face Controlled Study to Evaluate the Effectiveness of Topical Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% as Compared to Topical Tretinoin 0.05% + Hydroquinone 4% + Fluocinolone 0.01% for the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT07876323
- Acronym / sponsor ID
- 2021/01169
- Conditions
- Melasma, Melasma (Facial Melasma)
- Keywords
- melasma, eflornithine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Skin CentreResearch network
- Collaborators
- Agency for Science, Technology and Research (A*STAR)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 15 Oct 2026 (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 purpose of this study is to find out whether a new combination cream containing eflornithine, hydroquinone, and fluocinolone works better and causes fewer side effects than Tri-Luma® (tretinoin, hydroquinone, and fluocinolone), a commonly used treatment for melasma.
The main question is whether replacing tretinoin in Tri-Luma® with eflornithine leads to greater improvement in melasma and less skin irritation over a 12-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Split face study. Each subject will be randomized to apply eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream to one side of face and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream on the other side. The study creams will be packaged in identical containers so that the identity of the cream is not known.
| Arm | Type | Receives |
|---|---|---|
| Split face study comparing the effectiveness and safety of two different topical formulations | Other | Drug: Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream, Drug: Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% creamEvery subject receives both interventions at the same time, just on different randomized sides of the face. Each subject will be randomized to apply eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream to one side of face and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream on the other side. The study creams will be packaged in identical containers so that the identity of the cream is not known. Subjects and outcomes assessors were blinded to the treatment allocations. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults aged 25 to 75 years diagnosed with melasma, Fitzpatrick skin phototypes III or IV, provision of written informed consent, and similar melasma severity scale scores on both sides of the face at baseline.
Key exclusion criteria (1 listed)
- pregnant or lactating patients, patients known to be uncooperative, and patients with known contact allergy to any of the ingredients in the topical medications (such as eflornithine hydrochloride, hydroquinone, fluocinolone acetonide, tretinoin, methylparaben, or polyethylene glycol).
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 9.58% + Hydroquinone 4% + Fluocinolone 0.01% creamEach subject receives both interventions ( eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream) simultaneously, one on each randomized side of the face. | Drug | Split face study comparing the effectiveness and safety of two different topical formulations |
| Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% creamEach subject receives both interventions ( eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream) simultaneously, one on each randomized side of the face. | Drug | Split face study comparing the effectiveness and safety of two different topical formulations |
Primary outcome
modified Melasma Area and Severity Index (mMASI) score
Time frame: From enrolment to the end of treatment at 12 weeks
Calculated by assessing the area of involvement and the darkness of melasma across four facial regions. It yields a total score from 0 (clear) to 24 (severe)
Change from baseline in Melanin Index (M) measured using the SkinColorCatch®
Time frame: From enrolment to the end of treatment at 12 weeks
Melanin Index (M) will be measured objectively using the SkinColorCatch® colorimeter on each side of the face. The change in Melanin Index from baseline to month 3 will be calculated for each treatment side. The change from baseline will be compared between the side treated with eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% and the side treated with tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01%. Lower Melanin Index values indicate lower skin pigmentation.
Physician Global Assessment
Time frame: From enrolment to the end of treatment at 12 weeks
Obtained through a clinician's visual evaluation of the patient's facial hyperpigmentation, grading the overall severity on a standardized scale
Patient Global Assessment
Time frame: From enrolment to the end of treatment at 12 weeks
Obtained through patient's visual evaluation of their facial hyperpigmentation, grading the overall severity on a standardized scale
1 secondary outcome
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: From enrolment to the end of treatment at 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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream and Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream in people with Melasma and Melasma (Facial 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 1 inclusion and 1 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 15 Oct 2026. 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) score (time frame: From enrolment to the end of treatment at 12 weeks). The study lists 4 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 15 Oct 2026.