Reliability assessment and validation of the Melasma Area and Severity Index (MASI) and a new modified MASI scoring method.

BACKGROUND: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure for melasma, has not been validated. OBJECTIVE: We sought to determine the reliability and validity of the MASI. METHODS: After standardized training, 6 raters independently rated 21 patients with mild to severe melasma once daily over a period of 2 days to determine intrarater and interrater reliability. Validation was performed by comparing the MASI with the melasma severity scale. The darkness component of the MASI was validated by comparing it with the difference between mexameter scores for affected versus adjacent normal-appearing skin. The area component of the MASI was validated by comparing it with the area of each section of the face determined by computer-based measurement software. RESULTS: The MASI score showed good reliability within and between raters and was found to be valid when compared with the melasma severity scale, mexameter scores, and area measurements. Homogeneity assessment by raters showed the least agreement and can be removed from the MASI score without any loss of reliability. LIMITATIONS: Patients were limited to Hispanic, African, and Asian backgrounds. CONCLUSION: The MASI is a reliable measure of melasma severity. Area of involvement and darkness are sufficient for accurate measurement of the severity of melasma and homogeneity can be eliminated.

A prospective, randomized, split-face, controlled trial of salicylic acid peels in the treatment of melasma in Latin American women.

BACKGROUND: Melasma, a common disorder of hyperpigmentation, is often resistant to therapy. Although salicylic acid peels have been reported to be useful for patients with recalcitrant melasma, controlled trials are lacking. OBJECTIVE: We sought to determine the efficacy of salicylic acid peels when added to hydroquinone in the treatment of melasma. METHODS: Twenty Latin American women with moderate to severe bilateral melasma were treated with a series of 20% to 30% salicylic acid peels every 2 weeks for a total of 4 peels on one side of the face along with 4% hydroquinone cream to both sides of the face twice daily. The primary efficacy variable was reduction in pigmentation of the peeled side compared with the unpeeled side using narrowband reflectance spectrophotometry. RESULTS: Eighteen patients completed the study. Although both sides had significant reduction in pigment intensity, there was no difference between the peeled and unpeeled side with all outcome measures. LIMITATIONS: Patients were limited to Latin American women and only 4 peels were performed. CONCLUSION: A series of four 20% to 30% salicylic acid peels are not effective in the treatment of melasma when added to twice-daily 4% hydroquinone cream.

Continuous therapy followed by a maintenance therapy regimen with a triple combination cream for melasma.

BACKGROUND: Melasma is often recalcitrant to treatment. Triple combination (TC) cream is an effective and approved treatment for melasma. OBJECTIVE: We sought to determine the efficacy and safety of continuous therapy followed by a maintenance treatment regimen during a period of 24 weeks with a TC cream containing hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%. METHODS: Seventy patients with melasma were treated with a TC cream daily for 12 weeks, after which, if clear or almost clear, they applied the cream twice per week for 12 more weeks. For patients who were not clear or almost clear after 12 weeks, daily treatment was continued. RESULTS: In all, 25 patients completing the study per protocol were treated daily for 24 weeks (cohort A); 6 patients were treated daily for 12 weeks followed by 12 weeks of maintenance therapy (cohort B); and 21 patients were treated daily for 12 weeks, relapsed during the maintenance phase, and returned to daily dosing (cohort C). Pigmentation was significantly reduced at weeks 12 and 24 and global melasma severity improved at week 24 in cohorts A and C compared with baseline. Adverse events occurred in 53% of patients and were primarily mild in severity. LIMITATIONS: This was an open-label trial. CONCLUSION: About half of patients treated with a TC cream for melasma were able to begin maintenance therapy twice per week after 12 weeks; however, relapses occurred in most of these patients, requiring resumption of daily therapy. The cream is safe in the treatment of moderate to severe melasma for up to 24 weeks when used intermittently or continuously. Significant reductions in melasma severity scores were seen at weeks 12 and 24 when compared with baseline scores in all evaluable study groups.

Tolerability and efficacy of a novel formulation in the treatment of melasma.

BACKGROUND: Topical agents containing mixtures of hydroquinone and glycolic acid often cause irritation in patients with melasma. OBJECTIVE: The authors assessed the safety and efficacy of a new cream containing hydroquinone (HQ), glycolic acid, and hyaluronic acid for epidermal melasma. METHODS: Fifteen Latin American women with bilateral epidermal melasma underwent twice-daily full face application with the study cream for 12 weeks. A moisturizer was added if irritation developed. RESULTS: Mexameter data revealed that 14 of 15 patients (93%) improved, and there was a significant decrease in MASI (melasma area and severity index) scores of 64% over the course of the study. Fifty-three percent of the patients required a moisturizer after eight weeks of treatment. The majority of adverse events were mild. Patient and physician global evaluation showed moderate, obvious or very marked improvement in all patients. LIMITATIONS: Open, uncontrolled trial in a small number of patients. CONCLUSION: A cream containing hydroquinone, glycolic acid and hyaluronic acid demonstrates improvement in patients with melasma.

A histological examination for skin atrophy after 6 months of treatment with fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% cream.

Melasma is a common disorder affecting a significant percentage of the population, particularly those with skin of color. Therapy with hydroquinone, a depigmenting agent, as a single agent or in combination with other agents has been used with variable success. A triple-combination (TC) cream combining hydroquinone 4% with tretinoin 0.05% and fluocinolone acetonide 0.01% was developed for the treatment of melasma. We studied the use of TC cream for 24 weeks and had tissue samples for all time points in 62 patients with moderate to severe melasma. The atrophogenic potential of TC cream was evaluated through serial histopathologic examination of skin biopsies. No statistically significant histopathologic signs of atrophy of the epidermis or dermis were noted at any time point throughout the study. There was a marked reduction in epidermal melanin in treated subjects; however, we did not observe any significant difference in baseline and treated samples in the amount of perivascular inflammatory infiltrate, dermal mucin, keratinocyte and melanocyte atypia, or mast cells, consistent with findings of previous studies where topical retinoids were used. An increase in the mean number of blood vessels per square millimeter of tissue was observed in 2 study cohorts between baseline and week 24. These results suggest that the risk of skin atrophy with 24-week use of TC cream for the treatment of melasma is very low.

Efficacy of glycolic acid peels in the treatment of melasma.

BACKGROUND: Melasma is an acquired hypermelanosis that is often recalcitrant to treatment with hypopigmenting agents. OBJECTIVE: To assess the efficacy of 4% hydroquinone cream vs 4% hydroquinone cream combined with glycolic acid peels as treatment for melasma. METHODS: Twenty-one Hispanic women with bilateral epidermal and mixed melasma were enrolled in a split-faced prospective trial lasting 8 weeks. Patients underwent 20% to 30% glycolic acid peels every 2 weeks to one side of the face only in addition to twice-daily full-face application of 4% hydroquinone cream and sun protective factor 25 UV-B sunscreen each morning. Pigmentation was measured objectively using a mexameter and the Melasma Area and Severity Index and subjectively using a linear analog scale and physician and patient global evaluation. RESULTS: Hydroquinone treatment alone and treatment with the combination of hydroquinone and glycolic acid had a significant effect in reducing skin pigmentation compared with baseline (P<.001). However, no significant difference was found using combination therapy compared with hydroquinone alone (P =.75). CONCLUSIONS: Use of 4% hydroquinone and a daily sunscreen is effective in the treatment of melasma; however, the addition of 4 glycolic acid peels did not enhance the hypopigmenting effect of hydroquinone treatment alone.

Safety and efficacy of 4% hydroquinone combined with 10% glycolic acid, antioxidants, and sunscreen in the treatment of melasma.

BACKGROUND: Melasma, also known as mask of pregnancy, is a common, acquired hypermelanosis seen in women with Fitzpatrick skin types II-V, and is often recalcitrant to treatment with depigmentation agents. Glycolic acid has been added to hydroquinone formulations in the past to enhance their depigmentation effects, but may cause irritation, leading to postinflammatory hyperpigmentation. AIM: To assess the safety and efficacy of a cream containing 4% hydroquinone, 10% buffered glycolic acid, vitamins C and E, and sunscreen (Glyquin, ICN Pharmaceuticals, Costa Mesa, USA) vs. a cream containing sunscreen alone in the depigmentation of epidermal melasma of the face. METHODS: Thirty-nine Hispanic women, Fitzpatrick skin types III-V, with bilateral epidermal melasma were enrolled in a randomized controlled trial lasting 12 weeks. Patients underwent twice-daily full-face application with the study cream or with the cream containing sunscreen only. Changes in pigmentation were measured using a mexameter, the melasma area and severity index (MASI), and a global evaluation by the patient and blind investigator. Safety evaluations were performed at each follow-up visit. RESULTS: Thirty-five patients completed the trial. Irritation was more common with the study cream, but resolved with temporary cessation of cream application and the addition of moisturizers. Mexameter results demonstrated a significant decrease in the degree of pigmentation using the study cream compared with the cream containing sunscreen alone (P < 0.0001). Fifteen of 20 patients (75%) using the study cream improved, whereas only two of 15 patients (13%) improved using sunscreen alone. CONCLUSIONS: A cream containing 4% hydroquinone, 10% buffered glycolic acid, vitamins C and E, and sunscreen is safe and effective in the treatment of melasma.