CLINICAL TRIALS PROFILE FOR SOLARAZE

All Clinical Trials for Solaraze

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00204542 ↗	Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head	Completed	University Hospital Tuebingen	Phase 4	2005-06-01	Topical treatment of mild to moderate actinic keratosis located on 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 the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.
NCT00601640 ↗	Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin	Completed	National Cancer Institute (NCI)	Phase 2	2007-01-01	RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.
NCT00601640 ↗	Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin	Completed	University of Arizona	Phase 2	2007-01-01	RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.
NCT00777127 ↗	Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses	Completed	MEDA Pharma GmbH & Co. KG	Phase 4	2008-12-01	This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period.
NCT01358045 ↗	Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma	Completed	Maastricht University Medical Center	Phase 2	2011-11-01	Basal cell carcinoma (BCC) is the most frequent malignant tumor in Caucasians and the incidence is still increasing with 3-8% each year. Since BCCs generally occur on sun-exposed areas of the skin, the rice in incidence is mainly explained by the increasing exposure to (intermittent) ultraviolet radiation. Surgical excision is still the standard treatment for (micro)nodular BCCs. The costs as well as the increased workload are stressing the health care system even further and posing BCC an important health care problem. Since half of the BCCs arise primarily on the face & (bald) head and treatment by surgical excision may result in disfiguring scars, patients often experience a dramatic decrease of their quality of life. Hence, there is an urgent medical and societal need for a simple and cheap (targeted) treatment, preferably to be performed by the patients themselves. This treatment must be safe and effective. Such treatment is not available yet. BCC tumorigenesis is complex and must be multifactorial. Genetic alterations of multiple components of the Sonic Hedgehog (SHH) pathway are involved in sporadic BCC pathogenesis; inactivating mutations in Patched-1 (PTCH1) and activating mutations of Smoothened (SMO) and Suppressor of Fused (SU(FU)). With this knowledge, inhibition of the SHH pathway by SMO antagonists was successfully administered, however treatment resulted only in partial clinical response ofBCC. Recently, involvement of the Wingless (Wnt) pathway has been proven to be essential in BCC tumorigenic response. Moreover, a recent study of our own department provides the first evidence that epigenetic alterations, particularly promoter hypermethylation, influence both the SHH and Wnt pathway (own data, not published), which can serve as therapeutic targets. Both non-steroidal anti-inflammatory drugs (NSAlDS) and vitamin D derivatives are able to directly or indirectly target the Wnt pathway. Furthermore, vitamin D3 is able to inhibit Smoothened (SMO) in vitro, resulting in inhibition of the SHH pathway. Although in vivo studies are lacking, the investigators assume that topical application of these drugs may inhibit BCC growth and/or may cure BCC and thus might provide very promising future perspectives. Calcitriol and NSAlDs ointments are both already available for other indications and save in use. Eventually, our approach may result in a systematic approach to BCC, targeting (epi)genetic changes to treat and/or prevent further tumour growth.

Clinical Trial Conditions for Solaraze

Condition Name

Condition Name for Solaraze
Intervention	Trials
Actinic Keratosis	6
Actinic Keratoses	2
Basal Cell Carcinoma	1
Non-melanomatous Skin Cancer	1

Condition MeSH

Condition MeSH for Solaraze
Intervention	Trials
Keratosis, Actinic	9
Keratosis	9
Carcinoma, Basal Cell	1
Carcinoma	1

Clinical Trial Locations for Solaraze

Trials by Country

Trials by Country for Solaraze
Location	Trials
United States	47
Germany	6
Austria	2
France	1
Netherlands	1

Trials by US State

Trials by US State for Solaraze
Location	Trials
Florida	3
California	3
Virginia	3
South Carolina	3
Ohio	3

Clinical Trial Progress for Solaraze

Clinical Trial Phase

Clinical Trial Phase for Solaraze
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Solaraze
Clinical Trial Phase	Trials
Completed	10
Recruiting	1

Clinical Trial Sponsors for Solaraze

Sponsor Name

Sponsor Name for Solaraze
Sponsor	Trials
MEDA Pharma GmbH & Co. KG	2
University Hospital Regensburg	1
Actavis Inc.	1

Sponsor Type

Sponsor Type for Solaraze
Sponsor	Trials
Industry	10
Other	6
NIH	1

Solaraze: Clinical Trials, Market Analysis, and Projections

Introduction

Solaraze, a topical gel formulation of diclofenac sodium, is primarily used for the treatment of actinic keratoses (AK), a precursor to skin cancer. Here, we will delve into the clinical trials, market analysis, and projections for this medication.

Clinical Trials Overview

Clinical trials for Solaraze have been extensive and well-controlled, providing valuable insights into its efficacy and safety.

Efficacy

Solaraze has demonstrated significant efficacy in treating actinic keratoses. In several studies, the gel showed higher rates of complete clearance of AK lesions compared to vehicle-treated groups.

• Study Outcomes: In one study, 47% of subjects treated with Solaraze for 90 days achieved complete clearance of AK lesions on the scalp, forehead, face, arm/forearm, and back of the hand, compared to 19% in the vehicle group[2].
• Lesion Clearance Rates: Another study showed that after 60 days of treatment, 31% of Solaraze-treated subjects achieved complete clearance, compared to 10% in the vehicle group[2].

Safety and Adverse Events

While Solaraze is generally well-tolerated, it is associated with several adverse events, particularly those related to the skin and application site.

• Common Adverse Events: The most frequent adverse events included application site reactions such as contact dermatitis, rash, dry skin, and exfoliation. These reactions were significantly more prevalent in the Solaraze group than in the vehicle-treated group[1][3].
• Discontinuation Rates: Eighteen percent of Solaraze-treated subjects and 4% of vehicle-treated subjects discontinued the trials due to adverse events, primarily skin irritation and related cutaneous reactions[1][3].

Comparative Studies

A study comparing diclofenac sodium gel 3% (Actavis) to Solaraze (Fougera Pharms) aimed to evaluate the relative efficacy and safety of these formulations. While the study details are not fully available, it underscores the ongoing interest in optimizing diclofenac sodium gel formulations for AK treatment[4].

Market Analysis

Solaraze has a established presence in the market for topical treatments of actinic keratoses.

Market Sales

As of 2018, the annual market sales for Solaraze Gel 3% were approximately $31 million, as measured by IQVIA™. This figure indicates a significant market presence and demand for the product[5].

Generic Versions

The launch of generic versions, such as Perrigo's AB-rated generic version of Solaraze Gel 3%, has expanded access to this treatment. This move is expected to increase competition and potentially reduce costs for patients, further boosting market penetration[5].

Market Projections

Given the established efficacy and safety profile of Solaraze, along with the growing demand for topical treatments for actinic keratoses, several projections can be made:

Increasing Demand

The incidence of actinic keratoses is expected to rise due to increasing exposure to UV radiation and an aging population. This trend is likely to drive demand for effective topical treatments like Solaraze.

Competitive Landscape

The entry of generic versions will likely increase competition, which could lead to price reductions and greater affordability for patients. However, brand loyalty and the reputation of Solaraze may help it maintain a significant market share.

Expansion of Indications

While Solaraze is currently indicated for actinic keratoses, ongoing research and clinical trials may explore its potential in treating other skin conditions, further expanding its market.

Key Takeaways

• Efficacy: Solaraze has shown significant efficacy in treating actinic keratoses, with higher clearance rates compared to vehicle-treated groups.
• Safety: Common adverse events include skin and application site reactions, with a notable discontinuation rate due to these reactions.
• Market Presence: Solaraze has a substantial market presence, with annual sales of approximately $31 million as of 2018.
• Generic Competition: The introduction of generic versions is expected to increase competition and reduce costs.
• Future Projections: Increasing demand due to rising incidence of AK, competitive landscape changes, and potential expansion of indications.

FAQs

What is Solaraze used for?

Solaraze is used for the topical treatment of actinic keratoses (AK), a precursor to skin cancer.

What are the common adverse events associated with Solaraze?

Common adverse events include application site reactions such as contact dermatitis, rash, dry skin, and exfoliation.

How effective is Solaraze in treating actinic keratoses?

Solaraze has shown significant efficacy, with complete clearance rates of AK lesions ranging from 31% to 47% in different studies.

Are there generic versions of Solaraze available?

Yes, generic versions of Solaraze Gel 3% have been launched, such as Perrigo's AB-rated generic version.

What is the recommended dosage and duration of therapy for Solaraze?

The recommended dosage is to apply 0.5 g of gel (pea size) to each 5 cm x 5 cm lesion site twice daily, with a recommended duration of therapy from 60 to 90 days[3].

Sources

1. FDA Label: Solaraze (diclofenac sodium) Gel Label.
2. Drugs.com: Solaraze: Package Insert / Prescribing Information.
3. RxList: Solaraze (Diclofenac Sodium): Side Effects, Uses, Dosage.
4. ClinicalTrials.gov: A Study Comparing Diclofenac Sodium Gel 3% to Solaraze.
5. PR Newswire: Perrigo Launches Its AB Rated Generic Version of Solaraze Gel 3%.

Last updated: 2025-01-01