Solaraze (Diclofenac Sodium Topical) - Summary

SOLARAZE SUMMARY

SOLARAZE^® GEL
Diclofenac Sodium-3%

Solaraze^® (diclofenac sodium) Gel, 3%, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether.

Solaraze^® (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.

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NEWS HIGHLIGHTS

Media Articles Related to Solaraze (Diclofenac Topical)

Actinic Keratosis
Source: MedicineNet Psoriasis Specialty [2009.07.29]
Title: Actinic Keratosis
Category: Diseases and Conditions
Created: 10/29/2001 12:05:00 PM
Last Editorial Review: 7/29/2009

Understanding Actinic Keratosis
Source: MedicineNet Actinic Keratosis Specialty [2008.09.18]
Title: Understanding Actinic Keratosis
Category: Doctor's Views
Created: 9/18/2008
Last Editorial Review: 9/18/2008

Keratosis Pilaris
Source: MedicineNet Chronic Rhinitis Specialty [2008.08.06]
Title: Keratosis Pilaris
Category: Diseases and Conditions
Created: 8/4/2008
Last Editorial Review: 8/6/2008

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Published Studies Related to Solaraze (Diclofenac Topical)

Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. [2009.09]
OBJECTIVE: To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA)... CONCLUSION: Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665).

Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis. [2009.06]
While topical non-steroidal anti-inflammatory drugs are considered safe, their long-term efficacy for osteoarthritis has been suspect. We conducted a 12-week, double-blind, double-dummy, randomized controlled trial of topical diclofenac (TDiclo) in a vehicle solution containing dimethyl sulfoxide (DMSO) in 775 subjects with radiologically confirmed, symptomatic primary osteoarthritis of the knee...

Oral versus topical diclofenac for pain prevention during panretinal photocoagulation. [2009.06]
PURPOSE: To investigate the effect of pretreatment oral and topical diclofenac on pain reduction during panretinal laser photocoagulation (PRP) for proliferative diabetic retinopathy (PDR). DESIGN: Prospective, randomized, double-masked, placebo-controlled clinical trial. PARTICIPANTS AND CONTROLS: A total of 90 patients with PDR requiring PRP for the first time were assigned randomly to 1 of 3 study groups: oral diclofenac (n = 30), topical diclofenac (n = 31), or placebo (n = 29)... CONCLUSIONS: When given in a single dose, oral diclofenac is an effective pretreatment analgesic agent for reducing the pain experienced during PRP for PDR. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Effects of diclofenac epolamine patch on postoperative sore throat in parturients after cesarean delivery under endotracheal general anesthesia. [2009.03]
BACKGROUND: Postoperative sore throat is a common problem. The efficacy of topical application of non-steroidal anti-inflammatory drugs in alleviating postoperative sore throat has not been established. Our aim was to evaluate the analgesic effects of diclofenac epolamine patch on postoperative sore throat... CONCLUSION: The diclofenac epolamine patch is effective and safe in prevention of sore throat following intubation general anesthesia in cesarean section.

Evaluation of polysulfated glycosaminoglycan or sodium hyaluronan administered intra-articularly for treatment of horses with experimentally induced osteoarthritis. [2009.02]
OBJECTIVE: To assess clinical, biochemical, and histologic effects of polysulfated glycosaminoglycan (PSGAG) or sodium hyaluronan administered intra-articularly in treatment of horses with experimentally induced osteoarthritis.

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Clinical Trials Related to Solaraze (Diclofenac Topical)

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium [Completed]
The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18. 75 mg and 37. 5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

Assess Platelet Function and Safety After Administration of Injectable Diclofenac Compared to Ketorolac and Aspirin in Adult Male Volunteers [Completed]
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to cataflam, intravenous ketorolac and aspirin.

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain [Active, not recruiting]
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle.

The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis [Completed]
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.

The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.

Comparision of the Efficacy and Tolerability of Solaraze for 3 vs. 6 Months in Patients With Mild to Moderate Actinic Keratosis Located at the Face and Head [Recruiting]
Topical treatment of mild to moderate actinic keratosis located at the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses.

Therefore we evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice a day in face and head over 3 or 6 months of treatment.

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