Solagé ® Topical Solution contains mequinol 2% and tretinoin 0.01%, by weight, in a solution base of ethyl alcohol (77.8% v/v), polyethylene glycol 400, butylated hydroxytoluene, ascorbic acid, citric acid, ascorbyl palmitate, edetate disodium and purified water.
Mequinol is 4- hydroxyanisole, the monomethyl ether of hydroquinone or 1-hydroxy-4-methoxybenzene.
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling).
Solagé (mequinol 2%, tretinoin 0.01%) Topical Solution is indicated for the treatment of solar lentigines.
Solagé Solution should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program where the patient should primarily either avoid the sun or use protective clothing.
Neither the safety nor effectiveness of Solagé Solution for the prevention or treatment of melasma or postinflammatory hyperpigmentation has been established.
The efficacy of using Solagé Solution daily for greater than 24 weeks has not been established.
The local cutaneous safety of using Solagé Solution in non-Caucasians has not been adequately established (see Clinical Studies section).
Published Studies Related to Solage (Mequinol / Tretinoin Topical)
Mequinol 2%/tretinoin 0.01% solution: an effective and safe alternative to hydroquinone 3% in the treatment of solar lentigines. [2004.11]
A new topical solution containing 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% (Solage) was compared with its active components, its vehicle, and hydroquinone (HQ) 3% in the treatment of solar lentigines. In a randomized, parallel-group, double-masked study, 216 subjects applied the treatments twice daily for 16 weeks and were followed up for a further 24 weeks...
The combination of 2% 4-hydroxyanisole (Mequinol) and 0.01% tretinoin is effective in improving the appearance of solar lentigines and related hyperpigmented lesions in two double-blind multicenter clinical studies. [2000.03]
BACKGROUND: Solar lentigines are a chronic condition of the aging population resulting from years of cumulative sun exposure. A topical treatment that is both safe and effective would be welcome and useful. Combinations of therapeutic agents are often used and allow synergy of mechanisms with tolerability. A tyrosinase inhibitor in use in Europe, 4-hydroxyanisole (Mequinol), and the retinoid tretinoin have been used singly as depigmenting agents. OBJECTIVE: The efficacy and safety of the combination product of 2% 4-hydroxyanisole (4HA [mequinol]) /0.01% tretinoin solution (tradename Solage) were evaluated in two phase III, randomized, controlled, double-blind trials... CONCLUSION: For the treatment of solar lentigines and related hyperpigmented lesions, the topical combination product containing 2% 4HA/0.01% tretinoin solution is well tolerated and superior to either active component.
Safety and efficacy of combined use of 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% solution and sunscreen in solar lentigines. [2004.10]
The objective of this open-label, noncontrolled study was to evaluate the safety of a combination solution containing 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% (Solage) with a sunscreen in the treatment of solar lentigines. The study included a total of 406 subjects for a treatment period up to 24 weeks...
Percutaneous absorption of [3H]tretinoin and systemic exposure to mequinol after dermal application of 2% mequinol/0.01% [3H]tretinoin (Solage) solution in healthy volunteers. [1999.09]
Solage is a combination product composed of 2% mequinol (4-hydroxyanisole) and 0.01% tretinoin (all-trans-retinoic acid) in an ethanolic solution, which is being studied for its safety and efficacy as a topical treatment for disorders of skin hyperpigmentation.The safety of mequinol in this combination formulation is supported by the low systemic exposures of the subjects in this study compared with the systemic exposures at the highest doses in the dermal toxicity studies in mice (16.6-fold) and rats (34.6-fold).
Page last updated: 2006-01-31