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Harvard Business School
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Federal Trade Commission
Covington
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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR SOLARAZE

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Clinical Trials for Solaraze

Trial ID Title Status Sponsor Phase 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 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.
NCT00777127 Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses Completed MEDA Pharma GmbH & Co. KG Phase 4 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 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.
NCT01453179 Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2) Completed Accovion GmbH Phase 4 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 (Imiquimod) or Solaraze® 3% gel (Diclofenac) 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Solaraze

Condition Name

Condition Name for Solaraze
Intervention Trials
Actinic Keratosis 5
Basal Cell Carcinoma 1
Actinic Keratoses 1
Photosensitivity Disorders 1
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Condition MeSH

Condition MeSH for Solaraze
Intervention Trials
Keratosis, Actinic 7
Keratosis 7
Carcinoma 1
Photosensitivity Disorders 1
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Clinical Trial Locations for Solaraze

Trials by Country

Trials by Country for Solaraze
Location Trials
United States 32
Germany 5
Austria 2
Netherlands 1
France 1
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Trials by US State

Trials by US State for Solaraze
Location Trials
Virginia 2
Tennessee 2
South Carolina 2
Ohio 2
North Carolina 2
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Clinical Trial Progress for Solaraze

Clinical Trial Phase

Clinical Trial Phase for Solaraze
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Solaraze
Clinical Trial Phase Trials
Completed 7
Active, not recruiting 1
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Clinical Trial Sponsors for Solaraze

Sponsor Name

Sponsor Name for Solaraze
Sponsor Trials
MEDA Pharma GmbH & Co. KG 2
Accovion GmbH 1
Teva Pharmaceuticals USA 1
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Sponsor Type

Sponsor Type for Solaraze
Sponsor Trials
Industry 6
Other 5
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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
UBS
Johnson and Johnson
Fish and Richardson
Julphar
Harvard Business School
Merck
Cantor Fitzgerald
Baxter

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