Melasma Clinical Trial
Official title:
Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in the Treatment of Melasma: A Split Face Study.
Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 1, 2021 |
Est. primary completion date | February 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients with bilateral nearly symmetric melasma on the face. Exclusion Criteria: - Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study. - Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before - Patients active skin infections and active HSV - History of hypertrophic scars or keloids. - Patients with hypercoagulable state or bleeding diatheses - Pregnant and lactating females. - History of liver diseases - Intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants |
Country | Name | City | State |
---|---|---|---|
Egypt | Department of Dermatology, Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Paients' Satisfaction assessed by the VAS | a four-scale grading score: poor: response rate= 0-25%; fair: response rate= 25-50%; good: response rate=50-75%; excellent: response rate=75-100% | 2 months after final treatment | |
Primary | Hemi-Melasma Area and Severity Index (MASI) score | Hemi-Melasma Area and Severity Index(MASI) score for Pigmentation, and Area of involvement. The minimum value is 0 and the maximum value is 12. Higher scores mean a worse outcome. | 2 months after final treatment | |
Secondary | Melanin Index | Objective assessment of melanin index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome. | 2 months after final treatment | |
Secondary | Erythema Index | Objective assessment of erythema index using colorimeter apparatus. The minimum value is 0. No maximum value. Higher scores mean a worse outcome. | 2 months after final 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 | |
Completed |
NCT01695356 -
Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma
|
Phase 4 | |
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 | |
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 |