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Melasma

6
Pipeline Programs
9
Companies
13
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
0
0
0
3
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Galderma
GaldermaTX - Dallas
3 programs
3
Fluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%Phase 41 trial
Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%Phase 41 trial
Tri-Luma Maintenance regimenPhase 41 trial
Active Trials
NCT00469183Completed70Est. Apr 2007
NCT00669071Terminated56Est. Oct 2008
NCT00500162Completed340Est. Oct 2008
Combined Therapeutics
3 programs
3
Glycolic Acid 70%Phase 11 trial
Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic AcidPhase 11 trial
Tranexamic acidPhase 11 trial
Active Trials
NCT05362500Completed54Est. Nov 2021
NCT05887219Completed50Est. Apr 2023
NCT05884151Completed60Est. Apr 2023
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1565 nm non-ablative fractional laser combined with normal salineN/A1 trial
Active Trials
NCT06221787Recruiting80Est. Jul 2026
Fitzpatrick Company
Fitzpatrick CompanyON - Waterloo
1 program
DOSE formulationN/A1 trial
Active Trials
NCT04137263Completed24Est. Dec 2020
Color
ColorCA - Burlingame
1 program
Fractional 1927nm Low-Powered Diode LaserN/A1 trial
Active Trials
NCT05656833Unknown20Est. Jul 2023
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
Lytera 2.0N/A1 trial
Active Trials
NCT02977507Completed18Est. Oct 2017
Apollo Therapeutics
Apollo TherapeuticsUK - Cambridge
1 program
PicoSure 755nm picosecond alexandrite laser with diffractive lensN/A1 trial
Active Trials
NCT04602819Completed20Est. Feb 2022
Menarini
MenariniGermany - Dresden
1 program
Pigment Solution ProgramN/A1 trial
Active Trials
NCT06174545Unknown33Est. Dec 2023
DermBiont
DermBiontMA - Boston
1 program
SM-030 gel 0.64%PHASE_21 trial
Active Trials
NCT06454747Recruiting138Est. Oct 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GaldermaFluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
GaldermaTri-Luma Maintenance regimen
GaldermaFluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%
DermBiontSM-030 gel 0.64%
Combined TherapeuticsGroup A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid
Combined TherapeuticsTranexamic acid
Combined TherapeuticsGlycolic Acid 70%
MenariniPigment Solution Program
ColorFractional 1927nm Low-Powered Diode Laser
UNION therapeutics1565 nm non-ablative fractional laser combined with normal saline
Apollo TherapeuticsPicoSure 755nm picosecond alexandrite laser with diffractive lens
Fitzpatrick CompanyDOSE formulation
AbbVieLytera 2.0

Clinical Trials (13)

Total enrollment: 963 patients across 13 trials

NCT00669071GaldermaFluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%

Treatment w/ Tri-Luma® Cream & Intense Pulsed Light (IPL) vs a Mild Inactive Control Cream & Intense Pulsed Light (IPL) in Melasma

Start: Jan 2008Est. completion: Oct 200856 patients
Phase 4Terminated
NCT00500162GaldermaTri-Luma Maintenance regimen

Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma

Start: Nov 2006Est. completion: Oct 2008340 patients
Phase 4Completed
NCT00469183GaldermaFluocinolone acetonide .1%, hydroquinone 4%, tretinoin .05%

Assessment of Atrophogenic Potential of Triple Combination Cream for Treatment of Melasma

Start: May 2006Est. completion: Apr 200770 patients
Phase 4Completed
NCT06454747DermBiontSM-030 gel 0.64%

Randomized Study Using SM-030 Gel for Adults With Melasma

Start: Jun 2024Est. completion: Oct 2025138 patients
Phase 2Recruiting
NCT05887219Combined TherapeuticsGroup A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma

Start: Nov 2022Est. completion: Apr 202350 patients
Phase 1Completed
NCT05884151Combined TherapeuticsTranexamic acid

Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma

Start: Nov 2022Est. completion: Apr 202360 patients
Phase 1Completed
NCT05362500Combined TherapeuticsGlycolic Acid 70%

Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma

Start: Jun 2021Est. completion: Nov 202154 patients
Phase 1Completed
NCT06174545MenariniPigment Solution Program

Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma

Start: Sep 2023Est. completion: Dec 202333 patients
N/AUnknown
NCT05656833ColorFractional 1927nm Low-Powered Diode Laser

Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma

Start: Oct 2022Est. completion: Jul 202320 patients
N/AUnknown
NCT06221787UNION therapeutics1565 nm non-ablative fractional laser combined with normal saline

Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration

Start: Apr 2022Est. completion: Jul 202680 patients
N/ARecruiting
NCT04602819Apollo TherapeuticsPicoSure 755nm picosecond alexandrite laser with diffractive lens

Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma

Start: Jan 2021Est. completion: Feb 202220 patients
N/ACompleted
NCT04137263Fitzpatrick CompanyDOSE formulation

Study Evaluating the Efficacy of DOSE Formulations in Treating Melasma and Cutaneous Signs of Aging

Start: Oct 2019Est. completion: Dec 202024 patients
N/ACompleted
NCT02977507AbbVieLytera 2.0

Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Participants With Moderate Facial Melasma

Start: Dec 2016Est. completion: Oct 201718 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 actively recruiting trials targeting 963 patients
9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.