Melasma Clinical Trial
Official title:
Randomized Controlled Investigator Blinded Comparative Study of the Efficacy and Tolerability of Test Product Versus Cysteamine 5% in the Treatment of Facial Epidermal Melasma Over 4 Months
This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.
Melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. The objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus Cysteamine 5% in the acute management of melasma over 4 months. Statistics: Sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the Test Product versus Cysteamine 5% on the modified Melasma Area and Severity Index (mMASI) change from Baseline at Month 4. To allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at Month 4, 140 subjects in total (70 per group) are enrolled. Statistical analysis: Continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. For categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05013801 -
A Clinical Study to Evaluate the Effect of Facial Serum Q69 in Moderating the Appearance of Mild to Moderate Melasma
|
N/A | |
Recruiting |
NCT06174545 -
Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma
|
N/A | |
Completed |
NCT01695356 -
Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma
|
Phase 4 | |
Not yet recruiting |
NCT05911698 -
Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.
|
N/A | |
Recruiting |
NCT05656833 -
Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser for Treatment of Facial Melasma
|
N/A | |
Recruiting |
NCT04597203 -
Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial
|
N/A | |
Completed |
NCT02138539 -
Evaluation of an Herbal-Based De-Pigmenting System
|
Phase 4 | |
Recruiting |
NCT01661556 -
Clinical Trial of Hydroquinone Versus Miconazol in Melasma
|
Phase 4 | |
Completed |
NCT01001624 -
Melanil in the Treatment of Melasma
|
Phase 3 | |
Terminated |
NCT03415685 -
Lutronic PicoPlus Exploratory Clinical Trial
|
N/A | |
Recruiting |
NCT04765930 -
Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma
|
N/A | |
Completed |
NCT04137263 -
Study Evaluating the Efficacy of DOSE Formulations in Treating Melasma and Cutaneous Signs of Aging
|
N/A | |
Recruiting |
NCT03686787 -
Oral Tranexamic Acid and Laser for Treatment of Melasma
|
Phase 4 | |
Completed |
NCT05969587 -
Cysteamine Compared to Hydroquinone in Melasma
|
Phase 3 | |
Completed |
NCT00472966 -
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
|
Phase 4 | |
Completed |
NCT00500162 -
Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma
|
Phase 4 | |
Completed |
NCT05887219 -
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
|
Phase 1 | |
Completed |
NCT05884151 -
Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma
|
Phase 1 | |
Recruiting |
NCT03308370 -
Platelet Rich Plasma in Treatment of Melasma
|
Phase 3 | |
Not yet recruiting |
NCT05099601 -
Silymarin Cream Versus Combined Silymarin Cream and Microneedling in Treatment of Melasma
|
Phase 4 |