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临床试验/NCT00706433
NCT00706433已完成2 期

A Randomized, Evaluator-blinded, Parallel Group Light Dose Ranging Study of Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Levulan Topical Solution Vehicle + Blue Light on Moderate to Severe Facial Acne Vulgaris

DUSA Pharmaceuticals, Inc.14 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2007年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
266
试验地点
14
主要终点
Change in Inflammatory Lesion Counts Relative to Baseline
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.

详细描述

This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group light dose ranging study of photodynamic therapy in subjects with moderate to severe facial acne vulgaris.

Subjects will be randomized to one of the following four treatment groups (1:1:1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).

  • Group 1 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
  • Group 2 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
  • Group 3 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
  • Group 4 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)

Each subject may receive up to four treatments at three week (± 2 days) intervals. The power density (dose rate) and the total fluence (light dose) used at each treatment is intended to remain constant throughout each subject's participation. If a subject meets or exceeds the criteria restricting retreatment (CRR) prior to retreatment (Section 5.6), he/she will not receive additional PDT treatment at that visit and will be asked to return for the next scheduled PDT visit 3 weeks later, if applicable.

Post-treatment follow-up visits will be scheduled to occur at 3 and 6 weeks after the subject's final PDT.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 —（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subject is male or non-pregnant female 12 years of age or older.
  • •Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
  • •Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject.
  • •Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules).
  • •Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 [0 (clear) to 4 (severe) scale].
  • •Subject has a history of recurrent herpes simplex labialis infection in the treatment area AND has had an outbreak within the last 12 months must be placed on antiviral prophylaxis as specified in the protocol.
  • •Subject is willing to comply with study instructions and return to the clinic for required visits.
  • •Subject must have used the same type and brand of make-up, other facial products and hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior to the Baseline Visit (General Skin & Hair Care). Upon enrollment, all subjects must a) use exclusively an Investigator approved facial cleanser and b) agree to continue their other General Skin & Hair Care for the entire study.

排除标准

  • •Subject is pregnant, lactating, or is planning to become pregnant during the study.
  • •Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
  • •Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
  • •Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter)
  • •Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin).
  • •Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  • •Subject is currently enrolled in an investigational drug or device study.
  • •Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
  • •Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
  • •Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
  • •Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
  • •Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
  • •Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa antibiotics, phenothiazines, etc. within a timeframe where photosensitization from these drugs may still be present.
  • •Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the initiation of treatment.
  • •Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
  • •Subject has used any of the following topical anti-acne preparations on the face: a.) Topical anti-acne treatments including benzoyl peroxide, antibiotics, azelaic acid, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment b.) Retinoids, including tazarotene, adapalene, tretinoin within 4 weeks of the initiation of treatment. c.) Light treatments, microdermabrasion or chemical peels within 8 weeks of the initiation of treatment.
  • •Subject has used any of the following systemic anti-acne medications: a.) Corticosteroids (including intramuscular and intralesional injections) within 4 weeks of the initiation of treatment. Inhaled corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation of treatment). b.) Antibiotics within 4 weeks of the initiation of treatment. c.) Nicotinamide containing products within 4 weeks of the initiation of treatment. d.) Spironolactone within 8 weeks of the initiation of treatment. d.) Retinoid therapy within 6 months of the initiation of treatment.

研究组 & 干预措施

ALA 1000 seconds

Active Comparator

Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)

干预措施: aminolevulinic acid HCL (ALA) (Drug)

ALA 500 seconds

Active Comparator

Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)

干预措施: aminolevulinic acid HCL (ALA) (Drug)

Vehicle 1000 seconds

Placebo Comparator

Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)

干预措施: Vehicle (VEH) (Other)

Vehicle 500 seconds

Placebo Comparator

Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)

干预措施: Vehicle (VEH) (Other)

结局指标

主要结局

Change in Inflammatory Lesion Counts Relative to Baseline

时间窗: Baseline and 3 weeks after final treatment

Investigator Global Assessment of Acne Severity Successes

时间窗: Baseline and 3 weeks after final treatment

Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.

次要结局

  • Change in Inflammatory Lesion Counts Relative to Baseline(Baseline and 6 weeks after final treatment)
  • Subject Satisfaction Score(6 weeks after final treatment)
  • Percent Change in Inflammatory Lesion Counts Relative to Baseline(Baseline and 6 weeks after final treatment)
  • Investigator Global Assessment of Acne Severity Successes(Baesline and 6 weeks after final treatment)
  • Hyperpigmentation 48 Hours After PDT #1(48 hours after PDT #1)
  • Hyperpigmentation at Visit 3 (Week 3)(Visit 3 (Week 3))
  • Hyperpigmentation at Visit 5 (Week 6)(Visit 5 (Week 6))
  • Hyperpigmentation at Visit 7 (Week 9)(Visit 7 (Week 9))
  • Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)(Visit 9 (3 weeks after final PDT))
  • Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)(Visit 10 (6 weeks after final PDT))
  • Hypopigmentation 48 Hours Post PDT #1(48 hours post PDT #1)
  • Hypopigmentation at Visit 3 (Week 3)(Visit 3 (Week 3))
  • Hypopigmentation at Visit 5 (Week 6)(Visit 5 (Week 6))
  • Hypopigmentation at Visit 7 (Week 9)(Visit 7 (Week 9))
  • Hypopigmentation at Visit 9 (3 Weeks After Final PDT)(Visit 9 (3 weeks after final PDT))
  • Hypopigmentation at Visit 10 (6 Weeks After Final PDT)(Visit 10 (6 weeks after final PDT))
  • Erythema at Baseline (Pre-light)(Baseline (pre-light))
  • Erythema at Baseline - Post Light Treatment(Baseline - post light treatment)
  • Erythema 48 Hours After PDT #1(48 hours after PDT #1)
  • Erythema at Visit 3 (Week 3 - Pre Study Drug Application)(Visit 3 (Week 3 - pre study drug application))
  • Erythema at Visit 3 (Week 3 - Pre-light)(Visit 3 (Week 3 - pre-light))
  • Erythema at Visit 3 (Week 3 - Post Light Treatment)(Visit 3 (Week 3 - post light treatment))
  • Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)(Visit 5 (Week 6 - prior to study drug application))
  • Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)(Visit 5 (Weeks 6 - pre-light treatment))
  • Erythema at Visit 5 (Week 6 - Post Light Treatment)(Visit 5 (Week 6 - post light treatment))
  • Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)(Visit 7 (Week 9 - prior to study drug application))
  • Erythema at Visit 7 (Week 9 - Pre Light Treatment)(Visit 7 (Week 9 - pre light treatment))
  • Erythema at Visit 7 (Week 9 - Post Light Treatment)(Visit 7 (Week 9 - post light treatment))
  • Erythema 3 Weeks After Final PDT(3 Weeks after Final PDT)
  • Erythema 6 Weeks After Final PDT(6 Weeks after Final PDT)
  • Edema at Baseline - Pre Light Treatment(Baseline - pre light treatment)
  • Edema at Baseline - Post Light Treatment(Baseline - Post Light Treatment)
  • Edema 48 Hours After PDT #1(48 hours after PDT #1)
  • Edema at Visit 3 (Week 3 - Before Study Drug Application)(Visit 3 (Week 3 - before study drug application))
  • Edema at Visit 3 (Week 3 - Before Light Treatment)(Visit 3 (Week 3 - before light treatment))
  • Edema at Visit 3 (Week 3 - Post Light Treatment)(Visit 3 (Week 3 - post light treatment))
  • Edema at Visit 5 (Week 6 - Before Study Drug Application)(Visit 5 (Week 6 - before study drug application))
  • Edema at Visit 5 (Week 6 - Pre Light Treatment)(Visit 5 (Week 6 - pre light treatment))
  • Edema at Visit 5 (Week 6 - Post Light Treatment)(Visit 5 (Week 6 - post light treatment))
  • Edema at Visit 7 (Week 9 - Before Study Drug Application)(Visit 7 (Week 9 - before study drug application))
  • Edema at Visit 7 (Week 9 - Prior to Light Treatment)(Visit 7 (Week 9 - prior to light treatment))
  • Edema at Visit 7 (Week 9 - Post Light Treatment)(Visit 7 (Week 9 - post light treatment))
  • Edema 3 Weeks After Final PDT(3 weeks after final PDT)
  • Edema 6 Weeks After Final PDT(6 weeks after final PDT)
  • Stinging/Burning at Baseline - Before Light Treatment(Baseline - before light treatment)
  • Stinging/Burning at Baseline - During Light(Baseline - during light)
  • Stinging/Burning at Baseline - Post Light Treatment(Baseline - post light treatment)
  • Stinging/Burning 48 Hours Post PDT #1(48 hours post PDT #1)
  • Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)(Visit 3 (Week 3 - before study drug application))
  • Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)(Visit 3 (Week 3 - before light treatment))
  • Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)(Visit 3 (Week 3 - during light treatment))
  • Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)(Visit 3 (Week 3 - post light treatment))
  • Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)(Visit 5 (Week 6 - before study drug application))
  • Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)(Visit 5 (Week 6 - prior to light treatment))
  • Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)(Visit 5 (Week 6 - during light treatment))
  • Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)(Visit 5 (Week 6 - post light treatment))
  • Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)(Visit 7 (Week 9 - before study drug application))
  • Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)(Visit 7 (Week 9 - prior to light treatment))
  • Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)(Visit 7 (Week 9 - during light treatment))
  • Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)(Visit 7 (Week 9 - post light treatment))
  • Stinging/Burning at Visit 9 (3 Weeks After Final PDT)(Visit 9 (3 Weeks after Final PDT))
  • Stinging/Burning at Visit 10 (6 Weeks After Final PDT)(Visit 10 (6 Weeks after Final PDT))
  • Scaling and Dryness 48 Hours After PDT #1(48 hours after PDT #1)
  • Scaling and Dryness at Visit 3 (Week 3)(Visit 3 (Week 3))
  • Scaling and Dryness at Visit 5 (Week 6)(Visit 5 (Week 6))
  • Scaling and Dryness at Visit 7 (Week 9)(Visit 7 (Week 9))
  • Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)(Visit 9 (3 Weeks after Final PDT))
  • Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)(Visit 10 (6 Weeks after Final PDT))
  • Oozing/Vesiculation/Crusting 48 Hours After PDT #1(48 hours after PDT #1)
  • Oozing/Vesiculation/Crusting at Visit 3 (Week 3)(Visit 3 (Week 3))
  • Oozing/Vesiculation/Crusting at Visit 5 (Week 6)(Visit 5 (Week 6))
  • Oozing/Vesiculation/Crusting at Visit 7 (Week 9)(Visit 7 (Week 9))
  • Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)(Visit 9 (3 Weeks after Final PDT))
  • Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)(Visit 10 (6 Weeks after Final PDT))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (14)

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