A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatment Regimens on Subjects With Mild to Moderate Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- Global Face Total Lesion Count - Percent Change - Baseline to Week 12
研究概览
简要总结
This study will compare two different acne treatment regimens for the treatment of acne. Half of participants will receive a cleanser and a light therapy mask, while half of the participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy mask.
详细描述
Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompany sebaceous glands.
Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with red and blue light shown to target acne-causing bacteria and have an effect on inflammation reduction.
Light-based therapies have been used successfully to treat dermatological conditions since the early 1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet [UV], visible, near-infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer delivery of light to the skin in a gentler manner as compared to light delivered by lasers, primarily due to the lower energy output. It has been reported that LEDs do not deliver enough power to damage tissues and do not have the same risk of accidental eye damage that lasers do. Visible-LED light therapy has been deemed a non-significant risk by the U.S. Food and Drug Administration (FDA) and has been approved for use in humans.
It is well established in the literature that visible light penetration into the epidermal and dermal layers of human skin is primarily governed by absorption and scattering events, with the latter being the more impactful of the two. Visible light penetration into human skin can be increased by reducing scattering. This can be accomplished by temporary hydrogen bonding disruption, which leads to the reversible rearrangement of epidermal and dermal structures that cause scattering. Glycerol (i.e. glycerin) is hypothesized to generate the level of hydrogen bonding disruption described above, and therefore will be investigated in the present study.
This study will look to evaluate and then compare the acne clearing efficacy and tolerance of two different acne treatment regimens - a cleanser used with a currently marketed red and blue light acne light therapy mask alone vs. the cleanser used with the same mask in conjunction with a light therapy topical gel-cream - to determine the efficacy of these treatments and then to assess if the efficacy of the light therapy mask used with the topical gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in mild to moderate acne. If non-inferiority is demonstrated, the mask with topical gel-cream treatment will be further assessed for its superiority to the mask alone.
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 (Investigator, Outcomes Assessor)
盲法说明
Evaluator-blind
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has mild to moderate facial acne
- •Has 10-100 blackheads/whiteheads, 10-50 pimples, no cysts, and up to 2 large, hard, painful bumps (nodules)
- •Able to read, write, speak, and understand English
- •In general good health
- •Must agree to practice a medically acceptable form of birth control.
- •Intends to complete the study and willing to follow all study instructions.
排除标准
- •Very sensitive skin or allergies/sensitivity to skincare products or the test product ingredients.
- •Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results
- •Is using medication that makes skin more sensitive to light
- •Has severe acne or a pre-existing facial skin condition other than mild to moderate acne
- •has an immune deficiency disorder
- •has been using a product or medication that the stuff investigator determines will increase health risk to the subject or confuse the study results
- •Females that are pregnant, nursing, or planning to become pregnant
- •Males with a female partner who is pregnant or planning to become pregnant
- •Has excessive facial hair
- •Is participating in another study within past 4 weeks
- •Is related to the Sponsor, Investigator, or Study Site
结局指标
主要结局
Global Face Total Lesion Count - Percent Change - Baseline to Week 12
时间窗: Baseline and Week 12
Percent change from baseline in global face total lesion count at Week 12
次要结局
- Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12(Baseline to Week 8 and Week 12)
- Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8(Baseline to Week 4 and Week 8)
- Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4(Baseline to Week 2 and Week 4)
- Global Face Open Comedones Count - Week 2(2 weeks)
- Global Face Total Lesion Count - Week 8(8 weeks)
- Global Face Total Lesion Count - Percent Change - Baseline to Week 2(Baseline and Week 2)
- Global Face Total Lesion Count - Percent Change - Baseline to Week 4(Baseline and Week 4)
- Global Face Total Lesion Count - Percent Change - Baseline to Week 8(Baseline and Week 8)
- Global Face Open Comedones Count - Week 12(12 weeks)
- Global Face Inflammatory Lesion Count - Week 2(2 weeks)
- Global Face Inflammatory Lesion Count - Week 8(8 weeks)
- Global Face Non-Inflammatory Lesion Count - Week 2(2 weeks)
- Global Face Non-Inflammatory Lesion Count - Week 12(12 weeks)
- Investigator Global Acne Assessment - Week 1(1 week)
- Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits(Baseline to Week 2, Week 4, Week 8, and Week 12)
- Global Face Open Comedones Count - Week 4(4 weeks)
- Global Face Closed Comedones Count - Week 12(12 weeks)
- Investigator Global Acne Assessment - Week 8(8 weeks)
- Investigator Global Acne Assessment - Week 12(12 weeks)
- Overall Redness of Inflammatory Lesions - Week 1(1 week)
- Global Face Open Comedones Count - Week 8(8 weeks)
- Global Face Inflammatory Lesion Count - Week 12(12 weeks)
- Global Face Total Lesion Count - Week 12(12 weeks)
- Investigator Global Acne Assessment - Week 2(2 weeks)
- Global Face Non-Inflammatory Lesion Count - Week 4(4 weeks)
- Global Face Total Lesion Count - Week 4(4 weeks)
- Overall Redness of Inflammatory Lesions - Week 12(12 weeks)
- Global Face Closed Comedones Count - Week 2(2 weeks)
- Global Face Closed Comedones Count - Week 4(4 weeks)
- Global Face Closed Comedones Count - Week 8(8 weeks)
- Global Face Inflammatory Lesion Count - Week 4(4 weeks)
- Investigator Global Acne Assessment - Week 4(4 weeks)
- Overall Redness of Inflammatory Lesions - Week 4(4 weeks)
- Overall Size of Inflammatory Lesions - Week 2(2 weeks)
- Overall Size of Inflammatory Lesions - Week 12(12 weeks)
- Global Face Non-Inflammatory Lesion Count - Week 8(8 weeks)
- Global Face Total Lesion Count - Week 2(2 weeks)
- Overall Redness of Inflammatory Lesions - Week 2(2 weeks)
- Overall Redness of Inflammatory Lesions - Week 8(8 weeks)
- Overall Size of Inflammatory Lesions - Week 1(1 week)
- Overall Size of Inflammatory Lesions - Week 4(4 weeks)
- Overall Size of Inflammatory Lesions - Week 8(8 weeks)