Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Melasma has a significant impact on the quality of life and self-esteem of those affected. Darker skin photo types e.g. Egyptians have excess potential to develop melasma.
Melasma is a chronic and challenging condition to manage. Previous treatment modalities have been unsatisfactory.
Oral isotretinoin is a potential treatment modality for melasma that has not been investigated yet.
In this study we aim to evaluate the efficacy and the tolerability of oral isotretinoin in the treatment of melasma and to compare its efficacy and tolerability with the current gold standard "topical triple combination formula"
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotretinoin | Experimental | patients will receive oral isotretinoin (1 mg/kg/day) for 3 months |
|
| Kligman Formula arm | Active Comparator | patients will receive topical triple combination formula at night everyday over the affected areas for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotretinoin | Drug | Patients will receive 1mg/kg/day for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to complete clearance | The duration taken till complete clearance will be assessed as well. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Treatment tolerability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagar Nofal, Dr. | Contact | +201006387707 | hagarnofal@aucegypt.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University | Recruiting | Zagazig | Select Region | 44511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34411403 | Background | 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. | |
| 25781892 | Background |
Not provided
Not provided
The study protocol and a copy of the master sheet for data collection, the statistical analysis plan will be shared and the results will be published in a respective journal
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Triple combination formula |
| Drug |
Patients are instructed to apply the triple combination formula at night daily for 3 months |
|
|
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 |
| 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. |
| 27062273 | Background | 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. |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |