Efficacy of overnight leave-on sandwich therapy with 5% cysteamine and ectoine cream compared to hydroquinone 4% cream for treatment of melasma: a double-blind randomized controlled trial.
Summary
In a multicenter double-blind RCT, both 5% cysteamine + ectoine and 4% hydroquinone + ectoine significantly improved melasma by mMASI and JANUS-I with similar QoL gains, and no significant differences between groups. This supports cysteamine + ectoine as a viable alternative to hydroquinone in overnight leave-on 'sandwich' therapy.
Key Findings
- Double-blind multicenter RCT comparing 5% cysteamine + ectoine vs 4% hydroquinone + ectoine for melasma.
- Both groups showed reductions in mMASI and JANUS-I; between-group differences were not statistically significant (p > 0.05).
- Quality of life improved in both groups (MELASQoL, DLQI) without significant between-group differences.
- Demonstrated feasibility of overnight leave-on 'sandwich' therapy regimen in a controlled trial.
Clinical Implications
Cysteamine + ectoine can be considered when hydroquinone is contraindicated, unavailable, or poorly tolerated, using overnight leave-on protocols with monitoring for response and tolerability.
Why It Matters
Head-to-head RCT evidence informs first-line topical choices for melasma, an area with safety and regulatory concerns around hydroquinone. Demonstrates clinical equivalence in outcomes using objective and patient-reported metrics.
Limitations
- Sample size and exact follow-up duration are not reported in the abstract, limiting precision and long-term inference.
- Conducted in a single country; generalizability across diverse skin phototypes and settings requires confirmation.
Future Directions
Larger, longer-duration noninferiority trials stratified by phototype, with safety/tolerability profiling and cost-effectiveness analyses.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Double-blind randomized controlled trial comparing two topical regimens.
- Study Design
- OTHER