A Double Blinded, Prospective, Randomized, Stratified, Placebo-controlled, Multi-center Study of Photodynamic Therapy With VisonacTM Cream in Patients With Moderate to Severe Acne Vulgaris.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 11
- 主要终点
- Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.
研究概览
简要总结
The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)
详细描述
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age groups 9 to 12 years and 13 to 35 years and randomized to either Visonac or vehicle cream within each age group. All patients will receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be done after each treatment and at 12 weeks after the first treatment. Safety evaluations will be performed at each treatment visit and at 12 weeks after the first treatment.
Photographs of patients will be taken before and after treatment at first and last treatment visit, and at 12 weeks after first treatment.
Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment and at one week after last treatment visit.
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
- 9 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients, above 9 years of age with moderate to severe facial acne vulgaris (IGA score 3-4).
- •Female patients who are surgically sterile, pre-menstrual, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to T
- •Patients using birth control pills must have used the same product and dose for at least 6 months and must agree to stay with the same product and dose for an additional 6 months.
- •Fitzpatrick skin type I through VI.
- •Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face.
- •Patients with 30 to 120 non-inflammatory lesions (open and closed comedones) on the face.
- •Patients with no more than 2 nodular lesions on the face.
- •Signed and verified informed consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.
排除标准
- •Patients presenting with any of the following will not be included in the study:
- •Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •Patients unlikely to comply with the protocol, e.g., mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g., drug or alcohol abuse).
- •Female patients using oral contraceptives, that have not used the same product or dose within the last 6 months and do not agree to stay with the same product and dose for the duration of the study.
- •Pregnancy
- •Patients undergoing testosterone or any other systemic hormonal treatment.
- •Patients using hormonal contraceptives solely for the control of acne.
- •Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
- •Patients with porphyria.
- •Patients with cutaneous photosensitivity.
- •Participation in other clinical studies either concurrently or within the last 30 days, before T
- •Patients with a washout period for topical treatments e.g., topical BPOs, retinoids and antibiotics, for their acne of less than 14 days, before T
- •Medicated cleansers may be used during the washout period and stopped before the treatment.
- •Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month, before T
- •Patients with a washout period for oral isotretinoin of less than 6 months, before T
- •Patients with a beard or other facial hair that might interfere with study assessments.
- •Patients with melanoma or dysplastic nevi in the treatment area.
- •Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
- •Exposure to PDT within 12 weeks before T1.
研究组 & 干预措施
Visonac cream with PDT
Active treatment, Light dose 37 J/cm2.
干预措施: Visonac PDT (MAL PDT) (Drug)
Visonac cream with PDT
Active treatment, Light dose 37 J/cm2.
干预措施: PDT (Procedure)
Vehicle cream with PDT
Placebo treatment, Light dose 37 J/cm2.
干预措施: Vehicle cream (placebo) (Drug)
Vehicle cream with PDT
Placebo treatment, Light dose 37 J/cm2.
干预措施: PDT (Procedure)
结局指标
主要结局
Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.
时间窗: 12 weeks after the first treatment
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
时间窗: 12 weeks after the first treatment
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count
时间窗: 12 weeks after first treatment
次要结局
- Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count(12 weeks after the first treatment)
- Percent Change From Baseline in Facial Non Inflammatory Lesion Count(12 weeks after first treatment)
- Percent Change From Baseline in Facial Total Lesion Count(12 weeks after the first treatment)
- Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count(12 weeks after last treatment)
- Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline(12 weeks after first treatment)
- Absolute Change From Baseline in Facial Inflammatory Lesion Count(6 weeks after the first treatment)
- Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count(6 weeks after the first treatment)
- Absolute Change From Baseline in Facial Total Lesion Count(6 weeks after the first treatment)
- Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.(6 weeks after the first treatment)
- Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable(directly after fourth treatment)
- Proportion of Patients With Mild and Moderate Hyperpigmentation(at 12 weeks after first treatment)
- Proportion of Patients With Severe Hyperpigmentation(at 12 weeks after first treatment)
- Proportion of Patients With Mild or Moderate Scarring at End of Study(week 12)
- Proportion of Patients With Severe and Very Severe Scarring at End of Study(week 12)
- Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)(at 12 weeks after first treatment)
- Proportion of Patients With Dryness (Mild)(at 12 weeks after first treatment)
- Proportion of Patients With Clear or Almost Clear Scarring at End of Study(week 12)