NCT02952898已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
Balmoral Medical company16 个研究点 分布在 1 个国家目标入组 665 人开始时间: 2016年10月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 665
- 试验地点
- 16
- 主要终点
- Number of Subjects With Complete Clearance of AK Lesions
研究概览
简要总结
This research study is being done to compare the safety and effectiveness of GDC 695 (test drug) against the currently marketed reference drug (diclofenac sodium gel, 3%) and to establish that these two drugs work better than placebo in the treatment of actinic keratosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has provided written informed consent.
- •Immunocompetent male and/or non-pregnant female, 18 years of age or older.
- •Willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- •Clinical diagnosis of actinic keratosis.
- •In good general health and free of any disease state or physical condition.
- •Women, must be post-menopausal, surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
排除标准
- •Women who are pregnant, breastfeeding, or are planning to become pregnant or breastfeed during the study.
- •Is currently enrolled in another investigational drug or device study or has used an investigational drug or investigational device within 30 days prior to the Baseline Visit (Day 1).
- •Has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
- •Is immunosuppressed (e.g., human immunodeficiency virus [ HIV], systemic malignancy, graft host disease, etc.) or is taking medications that suppress the immune system.
- •Has experienced an unsuccessful outcome from previous topical diclofenac sodium therapy.
- •Has a history of sensitivity to any of the ingredients in the test articles or other excipients in the test or reference drug.
- •Has signs or symptoms consistent with the aspirin (ASA) triad.
- •Has used topical medications: corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid, etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >2%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, aminolevulinic acid (ALA) or prescription retinoids (e.g., tazarotene, adapalene, tretinoin), over-the-counter (OTC) products labeled as scrubs of any kind which are used to smooth the skin (as they contain some form of exfoliant such as nut shells, coffee grounds, polymer particles, etc.) within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit.
- •Has had cryodestruction or chemodestruction, curettage, photodynamic therapy (PDT), surgical excision, or other treatments for AK within the selected treatment area (face or bald scalp) within one month prior to the Baseline Visit.
- •Has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within one month prior to the Baseline Visit.
- •Has used oral isotretinoin within six months prior to the Baseline Visit.
- •Has used chemical peels, including but not limited to alphahydroxy acid, betahydroxy acid, bichloroacetic acid, trichloroacetic acid, and phenol within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit.
- •Has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, ultraviolet B (UVB) therapy, ALA-PDT, or dermabrasion within the selected treatment area (face or bald scalp) within six months prior to the Baseline Visit.
- •Has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or bald scalp).
- •Has active gastrointestinal ulceration or bleeding or has a history of gastrointestinal bleeds due to use of aspirin or other NSAIDs.
- •Has severe renal or hepatic impairment.
- •Has any condition which, in the investigator's opinion, could interfere with the evaluation of the test drugs or that could make it unsafe or preclude the subject's ability to fully participate in this research study.
研究组 & 干预措施
Test Drug
Experimental
GDC 695 gel applied topically as directed.
干预措施: GDC 695 (Drug)
Reference Drug
Active Comparator
Diclofenac sodium gel, 3% applied topically as directed.
干预措施: Diclofenac Sodium Gel, 3% (Drug)
Placebo
Placebo Comparator
Vehicle gel applied topically as directed.
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Number of Subjects With Complete Clearance of AK Lesions
时间窗: Day 90 (30 days after completion of 60 days of treatment)
Complete Clearance was defined as 100% clearance of all Actinic Keratosis (AK) lesions (having a count of zero AKs) in the treatment area (face or bald scalp) at the Day 90 visit (30 Days Post Treatment).
次要结局
未报告次要终点
研究者
研究点 (16)
Loading locations...
相似试验
已完成
3 期
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial VaginosisBacterial VaginosisNCT03091777Balmoral Medical company871
已完成
3 期
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne VulgarisAcne VulgarisNCT03717506Balmoral Medical company1,236
已完成
2 期
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe PsoriasisModerate to Severe Chronic Plaque PsoriasisNCT00601107Genzyme, a Sanofi Company111
已完成
3 期
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative ColitisUlcerative ColitisNCT01458574Pfizer593
已完成
2 期
Study Evaluating PD-0299685 for the Treatment of Vasomotor Symptoms (Hot Flashes / Flushes) Associated With MenopauseHot FlashesNCT00314964Pfizer527