Melasma Clinical Trial
Official title:
A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.
Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible light sunscreen. Visible light has melanotic properties and avoiding it can be part of the treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 25 per group. The purpose of this study is determine if there is a difference in the improvement between these two sunscreens types. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.
Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized
by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment
with sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard
in this condition.
Visible light has pigmenting properties that could be interfering with the treatment in
melasma patients. So, the primary objective of this study is to compare the depigmenting
adjuvant effect of using a UV-visible blocking sunscreen against a UV sunscreen.
Patients who are included in the study will be randomly assigned to receive one of the
sunscreen type, which should use for 12 weeks. The sun blocking agents should be applied in
the affected regions every 3 hours from 8AM to 5PM. The evaluation of clinical improvement
will be done in a blinded modality by means of the MASI score, the Global Physician
Assessment, as well as colorimetry and histological melanin content. Evaluations will be
held on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.
At the end of the study, data will be compared concerning the former parameters. All side
effects will be recorded and analysed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 | |
Recruiting |
NCT06278948 -
Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma
|
N/A | |
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 |
NCT05884151 -
Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma
|
Phase 1 | |
Completed |
NCT05887219 -
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in 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 |