In a phase 3 multicenter, randomized, double-blinded, placebo-controlled study of 120 patients with AK lesions:
- 79% decrease in target lesions at 30 days posttreatment1
- 50% of patients achieved complete clearance of all targeted lesions1
Solaraze Gel Tolerability
- In clinical trials, the most common adverse reactions involved the skin and included contact dermatitis, rash, dry skin and exfoliation2
- The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy2
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Solaraze® (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AKs). Sun avoidance is indicated during therapy.
Important Selected Safety Information
Do not use Solaraze® (diclofenac sodium) Gel if you have hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol or hyaluronate sodium. As with other non-steroidal anti-inflammatory drugs (NSAIDs), e.g. aspirin, severe rapidly-progressing allergic reactions may occur in patients without prior exposure to diclofenac. The most common side effects of Solaraze® Gel involves mild to moderately severe skin reactions, such as dermatitis, rash, dry skin and scaling of the skin. Avoid using Solaraze® Gel in patients with active ulcer affecting stomach or intestines and severe disorders of kidney or liver. Avoid sun exposure and concurrent use of sunscreens, cosmetics or other topical medications during Solaraze® Gel therapy. Do not apply Solaraze® Gel to broken skin, infections or inflamed red skin with scaling. Avoid contact with the eyes. Inform your doctor if you are taking other NSAIDs or if pregnant or nursing a baby. For more information, consult your healthcare provider. Please see the Full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088
- Data on file. PharmaDerm.
- Solaraze® Gel [Prescribing Information, 2010]. Melville, NY: PharmaDerm division of Fougera Pharmaceuticals Inc.