Clinical trials: Keratosis, Actinic
Actinic Keratosis
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the…
- Trial name
- NCT02654769
- Testing
- Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, Vehicle Foam
- Where
- 22 sites in United States
- Volunteers
- 441 people
- Sponsor
- Actavis Inc.
Actinic Keratoses
Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp
The aim of this study is to test the safety, tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light…
- Trial name
- NCT05662202
- Testing
- BF-200 ALA and red light LED lamp, Vehicle and red light LED lamp
- Where
- 14 sites in United States
- Volunteers
- 172 people
- Sponsor
- Biofrontera Inc.
Vulvar Lichen Sclerosus
The CO2RE® System for Vulvar Lichen Sclerosus
Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS…
- Trial name
- NCT04148651
- Testing
- The CO2RE® System
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- Candela Corporation
ACTINIC KERATOSIS
An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the…
- Trial name
- NCT03200912
- Testing
- Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, Vehicle Foam
- Where
- 23 sites in United States
- Volunteers
- 507 people
- Sponsor
- Actavis Inc.
Actinic Keratosis
Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis.
The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.
- Trial name
- NCT02799082
- Testing
- Vehicle, BF-200 ALA
- Volunteers
- 122 people
- Sponsor
- Biofrontera Bioscience GmbH
Actinic Keratosis
Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands
- Trial name
- NCT02137785
- Testing
- Aminolevulinic Acid (ALA), Topical Solution Vehicle, Blue Light Photodynamic Therapy Illuminator (BLU-U)
- Where
- 13 sites in United States
- Volunteers
- 269 people
- Sponsor
- DUSA Pharmaceuticals, Inc.
Actinic Keratosis
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
In topical photodynamic therapy (PDT) for non-melanoma skin cancers, a photosensitizing prodrug, 5-aminolaevulinic acid (ALA) or its methylated ester, methyl aminolevulinate (MAL), is converted to the endogenous photosensitizer…
- Trial name
- PDT (NCT02878382)
- Testing
- Conventional MAL-PDT, Calcipotriol assisted MAL-PDT
- Where
- 2 sites in Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Actinic Keratosis
Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
The study team had plans to treat approximately 30 subjects. Each subject that had qualified had at least 4-8 visible AKs on the face and/or scalp.
- Trial name
- NCT03914417
- Testing
- Imiquimod 3.75% Cream
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Actinic Keratosis, Photodynamic Therapy
Photodynamic Therapy-Induced Immune Modulation: Part III
This study is designed as a double-blinded proof of concept of feasibility study to define if the immunosuppression associated with photodynamic therapy (PDT) can be blocked by treatment with cyclo-oxygenase-2 (COX-2) inhibitor…
- Trial name
- NCT03643744
- Testing
- Celecoxib 200mg
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Wright State University
Actinic Keratosis
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant…
- Trial name
- NCT01000636
- Testing
- Metvix PDT
- Where
- United Kingdom
- Volunteers
- 9 people
- Sponsor
- Galderma R&D
Actinic Keratoses, Squamous Cell Carcinomas
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ…
- Trial name
- NCT01532453
- Testing
- MD-3511356, Standard Sun Protection Measures
- Where
- 10 sites in Austria, Czechia and 7 more
- Volunteers
- 244 people
- Sponsor
- Spirig Pharma Ltd.
Actinic Keratoses
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
- Trial name
- NCT00942604
- Testing
- PEP005 (ingenol mebutate) Gel, Vehicle gel
- Where
- 17 sites in United States
- Volunteers
- 203 people
- Sponsor
- Peplin
Actinic Keratosis
Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive…
- Trial name
- NCT02120456
- Testing
- LEO 43204
- Where
- 21 sites in United States, Canada
- Volunteers
- 224 people
- Sponsor
- LEO Pharma
Precancerous/Nonmalignant Condition
Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed.
- Trial name
- NCT00524485
- Testing
- aminolevulinic acid, laser therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Roswell Park Cancer Institute
Actinic Keratosis, Squamous Cell Carcinoma
A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp
One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC).
- Trial name
- NCT03115476
- Testing
- ingenol disoxate gel 0.018%, ingenol disoxate gel 0.037%, Vehicle gel
- Where
- 59 sites in United States, Canada and 4 more
- Volunteers
- 563 people
- Sponsor
- LEO Pharma
Actinic Keratosis
Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.
- Trial name
- NCT02838628
- Testing
- 50 mg of KX2-391 Ointment 1%
- Where
- 16 sites in United States
- Volunteers
- 168 people
- Sponsor
- Almirall, S.A.
Actinic Keratosis
To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis
The purpose of this study is to compare safety and efficacy of Perrigo's drug compared to an FDA approved drug in the treatment of actinic keratosis.
- Trial name
- NCT02459795
- Testing
- Ingenol Mebutate (Perrigo), Ingenol Mebutate (Reference)
- Volunteers
- 469 people
- Sponsor
- Padagis LLC
Actinic Keratoses
Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses
Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location.
- Trial name
- NCT02251652
- Testing
- Ingenol Mebutate, Cryotherapy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Actinic Keratosis
Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp.
- Trial name
- NCT00603798
- Testing
- Imiquimod cream
- Where
- 26 sites in United States
- Volunteers
- 490 people
- Sponsor
- Graceway Pharmaceuticals, LLC
Actinic Keratosis
A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis
- Trial name
- NCT01962987
- Testing
- Diclofenac sodium
- Where
- 31 sites in United States
- Volunteers
- 476 people
- Sponsor
- Actavis Inc.