Melasma research record
What do registered trials show for melasma?
No completed trial in this record posted a treatment result against a comparison group. The missing answer is the main finding.
The guide helps with care decisions. This page is the supporting trial record.
01
Treatment results
The absence is the finding. 60 completed melasma trials are registered, but only 4 posted numeric results — and none of the tracked treatment records include a result measured against a comparison group (every one of those result-posting records was scanned). For a condition this common, this registry cannot yet answer “did people improve because of the treatment?”. A product claiming proven results is not drawing on the record shown here: it may be citing trials registered in national registries this index does not cover, or studies never registered at all. Either way, the claim cannot be checked against the evidence on this page — so ask which trial it comes from.
You can still check below which treatments are being studied, who was included, and which trials are recruiting now.
Did a more expensive option beat the alternative?
The trials nobody ran
Among the most-studied melasma treatments, these pairs have never even appeared together in a registered trial — so no public evidence says which one is better:
- Tranexamic Acid ↔ Lasers, Solid-State
- hydroquinone ↔ Metformin
- hydroquinone ↔ Percutaneous Collagen Induction
- hydroquinone ↔ Lasers
- hydroquinone ↔ Lasers, Solid-State
- Tretinoin ↔ Metformin
Same molecule, different price tag
Regulatory status of the tracked treatments — whether the molecule studied in the trials above is available over the counter, as a generic, or brand-only. 7 of them have an OTC, generic, or biosimilar route.
| Treatment | Status | United States | Canada |
|---|---|---|---|
| azelaic acid (Finacea, Azelex)The 15% gel/foam (rosacea) and 20% cream (acne) contain the same molecule at different strengths; lower-strength azelaic acid also appears in cosmetics. | Generic prescription available | Finacea 15% gel (rosacea) has prescription generics; the 15% foam remains brand-only; Azelex 20% cream (acne) is brand-only. source | Finacea 15% gel is available in Canada by prescription. source |
| fluocinolone acetonide (Synalar, Tri-Luma)In melasma products, fluocinolone acetonide is combined with hydroquinone and tretinoin (Tri-Luma). | Generic prescription available | Generic prescription corticosteroid (creams, ointments, oils, solutions); in melasma it appears as one of the three molecules in the combination Tri-Luma. source | Prescription corticosteroid available in Canada; the Tri-Luma combination is also marketed. source |
| hydroquinone (Tri-Luma)The same molecule that once sold OTC at 2% in the US is now prescription-only there, while Canada still allows up to 2% without a prescription. | Generic prescription available | No longer sold OTC in the US — the 2020 CARES Act removed OTC skin-lightening hydroquinone (effective September 2020); available by prescription (typically 4%), and Tri-Luma is the only FDA-approved hydroquinone product. source | Concentrations up to 2% remain nonprescription in Canada; strengths above 2% were added to the Prescription Drug List (effective 2019). source |
| isotretinoin (Absorica, Accutane, Epuris)All isotretinoin capsule brands and generics contain the same molecule; low-dose use in rosacea is off-label in both markets. | Generic prescription available | Oral isotretinoin is generic (e.g., Claravis, Amnesteem, Absorica) and dispensed under the iPLEDGE safety program; rosacea use is off-label. source | Available by prescription as brands (Accutane, Clarus, Epuris) and generics. source |
| metformin (Glucophage)No metformin product is approved for melasma in the US or Canada; trial use involves the same molecule sold generically for diabetes. | Generic prescription available | Generic prescription tablets approved for type 2 diabetes; use for melasma (topical or oral) is off-label/investigational. source | Generic prescription metformin is available in Canada for diabetes; melasma use is off-label. source |
| tranexamic acid (Cyklokapron, Lysteda)No tranexamic acid product is approved for melasma in the US or Canada; oral use for melasma is off-label prescribing of the same molecule. | Generic prescription available | Generic prescription tablets (Lysteda) approved for heavy menstrual bleeding and injection for bleeding; use for melasma is off-label; topical forms are cosmetics. source | Cyklokapron and generics are available by prescription in Canada; melasma use is off-label. source |
| tretinoin (Retin-A, Altreno, Stieva-A)Prescription generics and brands contain the same molecule; unlike adapalene, no tretinoin product is sold OTC in the US or Canada. | Generic prescription available | Topical tretinoin creams and gels (0.01%-0.1%) are prescription generics; for melasma, tretinoin alone is off-label but it is one of the three molecules in the approved combination Tri-Luma. source | Prescription-only; available as brands (Retin-A, Stieva-A) and generics. source |
Regulatory status only, verified 2026-08-20 with one source per claim — not pricing, coverage, or a recommendation. Status can change; check the linked source.
Find one of 54 tracked treatments
Search by brand or generic name, or browse the 54 most-studied terms. They are ordered by what the public record can show, not by benefit or safety.
Who was in these trials?
- 100% of 18 counted participants were female.
- Race or ethnicity reported in 0 studies; skin phototype in 1.
- Fitzpatrick IV–VI (darker skin) reported: not in any tracked study — the record does not say how well this was tested on darker skin.
Who was in these trials?
- Average age 54 years (submitted means covering 20 participants).
- 100% of 20 counted participants were female.
- Race or ethnicity reported in 1 study; skin phototype in 0.
- Fitzpatrick IV–VI (darker skin) reported: not in any tracked study — the record does not say how well this was tested on darker skin.
52 more tracked treatments with no posted results — studied, but the public record holds no numbers yet
02
Who was studied?
2 of 4 result-posting melasma studies reported participants’ separately measured skin type.
Among 4 completed studies with posted results, this is how often each participant detail was reported.
- Adults eligible132
- Older adults eligible67
- Children eligible5
- All sexes eligible81
- Female participants eligible51
03
Research record
Open the part you need. Every count remains tied to this condition and snapshot.
4 of 60 completed trials posted results
56 completed trials did not post numeric results to the registry as of 2026-09-11. A missing result does not mean the treatment failed; it means the public cannot check what happened.
Among studies that ended at least 12 months ago, 4 of 52 (7.7%) posted results.
Who ran the trials and how they were designed
23% were led by industry, usually the company selling the treatment. This is context about who asked the question, not proof that a result is wrong.
- Not applicable74
- Phase 422
- Phase 212
- Phase 18
- Phase 37
- Early phase 14
- Phase 2 / Phase 34
- Phase 1 / Phase 21
- Other organization93
- Industry31
- Other government7
- Research network1
Lead sponsor class is not the same as all funding, and it is not a study-quality score.
Timelines and 29 active or recruiting trials
Registered study starts per year
Median study duration: 11 months.
Study starts by year (table)
| Year | Study starts |
|---|---|
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 6 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 4 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 5 |
| 2018 | 8 |
| 2019 | 12 |
| 2020 | 6 |
| 2021 | 7 |
| 2022 | 9 |
| 2023 | 13 |
| 2024 | 11 |
| 2025 | 15 |
| 2026 | 15 |
- United States26
- Pakistan16
- China11
- Egypt10
- Brazil9
- Indonesia9
- Mexico7
- France4
- +4 more6
Study locations are not participant nationality or ancestry.
Study counts, sources and limits
- clinical trials tracked
- 132
- completed trials with posted results
- 4 of 60
- submitted enrollment
- 3,233
- active or recruiting now
- 29
ClinicalTrials.gov data through · methodology v2.1.0 · snapshot 9a17314144e5…
What these figures cannot tell you
- Registry records are submitted by sponsors and investigators; Skinlogie processes selected fields but does not independently verify every record.
- Nothing here is a pooled estimate of whether one treatment works better or causes fewer harms — results stay tied to their single study, outcome, comparator, and time point.
- “Completed” is a registry status, not a judgment of study quality, risk of bias, or selective reporting; posted results are not the complete journal literature.
- Study counts and research activity measure how much research is visible, not how well a treatment works.
- Enrollment sums count submitted participant entries, not guaranteed unique people; reported categories cannot show whether a population was representative or whether subgroup findings apply to you.
- A between-group difference can estimate a comparative effect only when groups and outcome are clear enough; a percentage observed in a single group cannot show what would have happened without treatment.
- This index cannot decide whether a treatment is safe or suitable for you — that depends on benefits and harms, your preferences, and your health context.
Plain-language definitions
- Placebo
- A look-alike with no medicine in it, so trials can separate the treatment’s effect from expectation and time.
- Vehicle
- The same cream or gel without the active ingredient — the fair comparison for topicals, because the base alone can moisturize.
- Comparative result
- A posted number for the treatment group and a comparison group in the same trial. Only this kind of result can show the treatment itself made the difference.
- Primary outcome
- The one measurement a trial named in advance as its test of success — harder to cherry-pick than outcomes chosen after the fact.
- Phase 3
- The large, late-stage trials regulators rely on. Phase 1 and 2 are smaller and earlier; Phase 4 studies happen after approval.
- Industry-run
- The registered lead sponsor is a company — usually the one selling the treatment. Not proof of bias, but worth knowing who asked the question.
- Biosimilar
- A close copy of a biologic drug approved as equivalent — the “generic” route for biologics, typically sold at a lower price.
- n=
- How many people were analysed in a group. Bigger groups give steadier numbers.
Source: official ClinicalTrials.gov search · snapshot · result-mapping layer (v1.1.0, 2026-08-21) · field guide and citation.
Cite or reuse this resultCopy the dated, source-linked sentence
Citation text
As of 2026-09-11, 4 of 60 completed melasma trials registered on ClinicalTrials.gov have posted results — none has posted a result against a comparison group (Skinlogie Evidence Index, https://skinlogie.com/evidence-index/melasma).
Skinlogie’s derived figures are licensed CC BY 4.0 — reuse them with this attribution. Source records: ClinicalTrials.gov. Full dataset and citation format →