Melasma Clinical Trial
Official title:
Oral Isotretinoin in The Treatment of Melasma A Randomized Controlled Clinical Trial
Melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. Melasma is challenging to treat. Treatment is often a multimodality approach. Due to the attached psychological and social stress, it is important to counsel patients with melasma adequately about the chronicity of the disease, the importance of photoprotection, and the role of hormones in disease persistence before embarking on therapeutic correction. So in this study, we are exploring the efficacy of oral isotretinoin for treating melasma.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 and 50 years 2. Patients complaining of melasma. 3. Patients with all types of melasma (epidermal, dermal and mixed) 4. Sexually active women who is willing to follow at least 2 types of contraceptive methods during study period 5. Patients with skin type I-V Exclusion Criteria: 1. Pregnant or nursing women. 2. Women on any concurrent therapy for melasma. 3. Patients that are using any therapy for melasma for the last 45 days. 4. Patient with abnormal liver function test or lipid profile. 5. Patients with allergy or hypersensitivity to the assigned drugs. 6. Women not willing to follow contraceptive methods at time of study. 7. Patients on facial treatments or photosensitizing drugs within previous 6 months. 8. Patients with back or joint pain. 9. Patients with pre-existing or dormant dermatologic disease on the face that could interfere with the outcome of the study |
Country | Name | City | State |
---|---|---|---|
Egypt | Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University | Zagazig | Select Region |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Artzi O, Horovitz T, Bar-Ilan E, Shehadeh W, Koren A, Zusmanovitch L, Mehrabi JN, Salameh F, Isman Nelkenbaum G, Zur E, Sprecher E, Mashiah J. The pathogenesis of melasma and implications for treatment. J Cosmet Dermatol. 2021 Nov;20(11):3432-3445. doi: 10.1111/jocd.14382. Epub 2021 Aug 19. — View Citation
Garner ML, McShane DB, Burkhart CN, Morrell DS. Isotretinoin and vitiligo: can chronic cheilitis cause koebnerization? Pediatr Dermatol. 2015 May-Jun;32(3):e108-9. doi: 10.1111/pde.12538. Epub 2015 Mar 17. — View Citation
Muthu SK, Narang T, Saikia UN, Kanwar AJ, Parsad D, Dogra S. Low-dose oral isotretinoin therapy in lichen planus pigmentosus: an open-label non-randomized prospective pilot study. Int J Dermatol. 2016 Sep;55(9):1048-54. doi: 10.1111/ijd.13293. Epub 2016 Apr 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to treatment | Treatment efficacy will be assessed by the change in disease severity measured in mMASI at the end of the treatment period, and the difference in the global appearance of melasma through standardized photographs using Global Aesthetic Improvement Scale (GAIS) using a five-point ordinal scale (1 = exceptionally improved appearance, 2 = very improved appearance, 3 = improved appearance, 4 = unaltered appearance, 5 = worsened appearance). The duration taken till complete clearance will be assessed as well. | three months | |
Primary | Time to complete clearance | The duration taken till complete clearance will be assessed as well. | 12 weeks | |
Secondary | Quality of life index | The change in patients' quality of life using the difference between results of "Melasma Quality of Life Index" at baseline and end of treatment. | 12 weeks | |
Secondary | Treatment tolerability | Treatment tolerability will be assessed in terms of the side effects reported by the investigator or the patients in follow-up visits including but not limited to; facial erythema, scaling, a burning sensation, and cheilitis. Patients' compliance assessed by the percentage of patients withdraw from each arm of the study and the number of days per week the patients' take/apply their medication. | 12 weeks |
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 | |
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 |
NCT00500162 -
Comparison of Two Tri-Luma® Maintenance Regimens in the Treatment of Melasma
|
Phase 4 | |
Completed |
NCT00472966 -
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for 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 |