Randomized, Double-blinded, Split-face Study Comparing the Cosmetic Efficacy and Tolerability of Two Topical Products in Subjects With Moderate Facial Melasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change From Baseline in Melasma Severity Rating Scale Score to Week 12
研究概览
简要总结
The objective of this study is to evaluate the efficacy and tolerability of Lytera 2.0 versus 4% hydroquinone in the improvement of the appearance of moderate facial melasma.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male aged 18+ years with general good health
- •Individuals with dark patches on both sides of their face
- •Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English.
- •Individuals willing to sign have their photographs taken during the study and are willing to sign a photography release.
- •Willing to stop all facial treatments during the course of the study including botulinum toxin, injectable fillers, microdermabrasion, Intense pulsed light (IPL), peels, facials, waxing, laser treatments and tightening treatments. Threading is allowed but not facial laser hair removal.
- •Willingness to cooperate follow all study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
- •Willingness to not begin using any new cosmetic facial make-up during the study. If you regularly use cosmetic facial make-up, you must have used the product(s) without any issues for at least 2 weeks prior to starting the study.
- •Willingness to avoid sun exposure to the face as much as possible, (including tanning beds), especially from 10 AM to 2 PM. Protective clothing (i.e. hats) and the provided sunscreen should be worn prior to and during any exposure.
排除标准
- •Individuals diagnosed with known allergies to study provided skin care products.
- •Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- •Individuals with a history of skin cancer.
- •Individuals having a health condition on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations etc.).
- •Individuals with a history of immunosuppression/immune deficiency disorders (including (Human immunodeficiency virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation.
- •Individuals with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- •Individuals with any planned surgeries and/or invasive medical procedures during the course of the study.
- •Individuals who are currently participating in any other facial usage study or have participated in any clinical trial within 4 weeks prior to inclusion into the study.
- •Individuals who have observable suntan, scars, nevi, excessive hair, etc. or other dermal conditions on the face that might influence the test results in the opinion of the Investigator or designee.
- •Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- •Individuals who used any of the following medications or had any of the listed procedures within the listed time frame prior to the study start date:
- •Retin-A®, Retin-A Micro®, Renova®, Avita®, Tazorac®, or Differin® within 3 months
- •Had a light-depth chemical peel or microdermabrasion within 1 month
- •Had a medium-depth chemical peel, medium-depth microdermabrasion, any systemic steroids, non-ablative laser, light and/or radio frequency or fractional laser resurfacing of the face and neck within 3 months
- •Any systemic retinoid (e.g. Soriatane®, Accutane®, Roche Dermatologics) within 12 months
- •Any topical or systemic antibiotics, such as minocycline, or any other known medications that can cause photosensitivity, such as hydrochlorothiazide, lasix, amiodarone, within 1 month
- •Any topical tretinoin product or derivative, imiquimod, 5-fluorouracil, or diclofenac on their face within 3 months
- •Prescription strength skin lightening products (e.g. 4% hydroquinone, tretinoin, alpha hydroxy acid (AHA), beta hydroxy acid (BHA) and polyhydroxy acids, 15% or 20% azelaic acid, 4-hydroxyanisole alone or in combination with tretinoin, etc.) within 3 months
- •Any non-prescription cosmetic anti-wrinkle, skin lightening products, or any other product or topical or systemic medication known to affect skin aging or dyshcromia (products containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within 2 weeks
- •Have undergone plastic surgery, Dermabrasion (deep skin peel), a deep chemical peel or ablative laser resurfacing of the face and neck within 12 months
- •Had facial treatment with a botulinum toxin base injectable (Botox), injectable fillers, or a fat transfer within 6 months
研究组 & 干预措施
Lytera 2.0
Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: Lytera 2.0 (Other)
Lytera 2.0
Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: SkinMedica Facial Cleanser (Other)
Lytera 2.0
Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: SkinMedica Rejuvenative Moisturizer (Other)
Lytera 2.0
Lytera 2.0 applied to the affected areas (dark patches) on one side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen (Other)
4% Hydroquinone Topical Cream
4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: 4% Hydroquinone Topical Cream (Drug)
4% Hydroquinone Topical Cream
4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: SkinMedica Facial Cleanser (Other)
4% Hydroquinone Topical Cream
4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: SkinMedica Rejuvenative Moisturizer (Other)
4% Hydroquinone Topical Cream
4% hydroquinone topical prescription cream applied to the affected areas (dark patches) on the other side of the face twice a day, in the morning and evening, every day for 12 weeks. SkinMedica Facial Cleanser, SkinMedica Rejuvenative Moisturizer, and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen were also applied to the face as directed.
干预措施: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen (Other)
结局指标
主要结局
Change From Baseline in Melasma Severity Rating Scale Score to Week 12
时间窗: Baseline (Day 1) to Week 12
The investigator assessed the participant's facial skin for the severity of symmetrical facial melasma on the left and the right side of the face using the Melasma Severity Rating Scale. The score ranges from 0 to 3, where 0=Cleared: color of melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation, 1=Mild: color slightly darker than the surrounding normal skin, 2=Moderate: color moderately darker than the surrounding normal skin and 3=Severe: color markedly darker than the surrounding normal skin. A negative change from Baseline indicates improvement.
Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12
时间窗: Baseline (Day 1) to Week 12
The investigator assessed the participant's left and right facial sides for overall hyperpigmentation using the Overall Hyperpigmentation ten-point scale ranging from 0 to 9, where Score 0=None, skin is normal in color with no evidence of hyperpigmentation; Score 1, 2 or 3=Mild, several brown spots with increased pigmentation, they are small in size and slightly darker than surrounding skin; Score 4, 5 or 6=Moderate, many brown spots with increased pigmentation, they are medium in size and much darker than surrounding skin; Score of 7, 8 or 9=Severe, many large brown spots with increased pigmentation, they are large in size and markedly darker than surrounding skin. A negative change from Baseline indicates improvement.
Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12
时间窗: Baseline (Day1) to Week 12
The investigator assigned a grade for the left and right facial sides for each of the following: A=Total Area Involved (0=No involvement to 6=90 to 100% involvement); D=Darkness of Pigment (0=Normal skin color to 4=Severe hyperpigmentation); and H=Homogeneity (0=Normal skin color without evidence of hyperpigmentation to 4=Uniform skin involvement without any clear areas). Total Half-Face MASI score was calculated as: Half Forehead 0.15(D+H)A + One Malar Side 0.3 (D+H)A + Half Chin 0.05(D+H)A. A negative change from Baseline indicates improvement.
次要结局
- Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition(Baseline (Day 1) to Weeks 4, 8 and 12)
- Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product(Weeks 4, 8 and 12)
- Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference(Weeks 4, 8 and 12)
- Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12(Baseline (Day 1) to Week 12)
- Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12(Week 12)
- Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12(Baseline (Day 1) to Week 12)