Improvement (lightening) of the solar lentigines occurred gradually over time during the 24 week treatment period. At 24 weeks of treatment, 57% and 54% of patients experienced moderate improvement or greater, and 3% and 1% of patients were completely clear of all treated lesions for the face and forearms/back of hands, respectively. It should be noted that approximately 9% of patients, from both treatment areas in these studies, with moderate improvement or greater also experienced hypopigmentation of the skin surrounding at least one treated lesion. There are no vehicle-controlled effectiveness data on the course of lesions treated beyond 24 weeks. After 24 weeks of treatment, for the forearm/back of hands treatment site, the percentage of patients treated with tretinoin topical solution with moderate improvement or greater, slight improvement, or no change, were 38%, 37%, and 26%, respectively, and for mequinol topical solution were 24%, 40%, and 36%, respectively. For the face treatment site, the percentage of patients treated with tretinoin topical solution with moderate improvement or greater, slight improvement, or no change, were 46%, 33%, and 21%, respectively, and for mequinol topical solution were 33%, 30%, and 37% respectively.

The duration of effect was investigated during a period of up to 24 weeks following the discontinuation of treatment. Results from these studies showed that patients may maintain the level of clinical improvement of their treated lesions from the end of treatment through the 24 week follow-up period. However, some degree of repigmentation of treated lesions was observed over time, demonstrating reversibility of the depigmenting action of Solagé Solution. In the pivotal clinical trials of 24 weeks duration, some patients experienced temporary hypopigmentation of treated lesions (5%) or of the skin surrounding treated lesions (7%). Hypopigmentation of the skin surrounding treated lesions occurs even in the setting of proper application of the drug within the lesion border. The majority (94/106 - 89%) resolved upon discontinuation of treatment to the lesion, and/or re-instruction on proper application to the lesion only. Another 8% (9/106) of patients with hypopigmentation events had resolution within 120 days after the end of treatment.

Three of the 106 patients (2.8%) had persistence of hypopigmentation beyond 120 days. This further demonstrates the reversibility of the depigmenting action of Solagé Solution. Over 150 patients used Solagé Solution twice daily for 52 weeks in an open label clinical study. The safety profile for Solagé Solution in this long-term study was similar to that seen in the 24 week studies although burning/stinging/tingling, desquamation, pruritis, and irritation of the skin occurred at lower rates and halo hypopigmentation and hypopigmentation occurred at a slightly greater rate.

Over 90 patients used Solagé Solution twice daily and a concomitant sunscreen (PreSun® 29) daily for up to 24 weeks in an open label clinical study. The safety profile for Solagé Solution in this study was similar to that seen in studies which prohibited sunscreen use although desquamation, pruritis, and halo hypopigmentation occurred at slightly lower rates. The initial clinical trials for Solagé Solution included 1794 individuals of Skin Type I-V, 94.5% of whom were Caucasian. The trials also included 5% of individuals who were Asian/Pacific Islander (1.2%), African-American (0.8%), and Hispanic/Latino (3.5%). An additional open label study was conducted in 259 patients in the Asian (24.3%), Hispanic/Latino (62.2%) and African American (13.5%) ethnic groups with skin types II to V. This number reflects approximately three times as many subjects in this population as were represented in the initial clinical trials. In this study, as in the earlier studies, Solagé Solution was used twice daily for a period of 24 weeks. The overall safety profile in this study was generally consistent with the initial clinical trials although erythema, desquamation, and pruritis occurred at lower rates and halo hypopigmentation occurred at a higher rate (7.7% versus 6.2%). The safety of Solagé Solution in women of childbearing potential has not been established (see CONTRAINDICATIONS).

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