A Randomized, Observer-Blinded, Placebo-Controlled Study on the Safety and Efficacy of Twice Daily Application of SM-030 Gel 0.64% Vs. SM-030 Gel 0.08% Vs. Placebo Gel in Adults With Melasma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations
研究概览
简要总结
Brief Summary This is a phase 2b, observer-blinded, randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 0.64% and SM-030 gel 0.08% compared against placebo gel in healthy adult male and female subjects with Melasma. The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period. Approximately 138 subjects who meet the eligibility criteria, notably with a clinical diagnosis of Melasma will be randomized in a 3:2:1 ratio to one of three treatment arms: SM-030 gel 0.64% (N=69), Placebo gel (N=46), or SM-030 gel 0.08% (N=23). Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites (4 sites in Mexico and 1 in El Salvador). Subjects will be assessed for safety and efficacy at each 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Subjects who meet any of the following criteria will be excluded in the study:
- •Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study.
- •Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to vitiligo affecting the treatment and comparison sites.
- •Severe photodamage as assessed by the 10-point photo damage assessment scale (Griffiths et al., 1992); (McKenzie et al., 2011).
- •Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).
- •Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.
- •Current or past use of monobenzyl ether to depigment skin.
- •Use of the following topical preparations within a 28-day washout period: topical corticosteroids, topical bleaching products (hyroquinone, niacinamide, kojic acid, ascorbic acid, chemical peels, topical tranexamic acid (TXA)), UV light therapy and sunbathing, topical retinoids.
- •Use of the following systemic agents within the specified washout periods:
- •Systemic corticosteroids (28 days)
- •Systemic cyclosporine, interferon (6 months)
- •Systemic acitretin, etretinate, isotretinoin (6 months)
- •Systemic methotrexate (6 months)
- •Systemic tranexamic acid (TXA)
- •Systemic photoallergic, phototoxic, and or photosensitizing drugs (6 months including psoralens, sulfonamide drugs, tetracycline antibiotics, thiazide diuretics, phenothiazines, coal tar and derivatives, and tricyclic antidepressants, chlorpromazine, benoxaprofen, piroxicam, nalidixic acid, procainamide, phenytoin, antimalarial medications, some cystostatic agents)
- •Laser (ablative or non-ablative), microneedling, PRP, or light-based treatment of the treatment areas within 3 months of Screening.
- •Any dermatological conditions within the designated application area that could interfere with clinical evaluations or any disease state or physical condition which might expose the subject to an unacceptable risk by study participation (neurodermatitis, eczema, psoriasis, atrophy, rosacea, seborrheic dermatits, etc.).
- •Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see Exclusion criteria 6, 7, and 8).
- •Known high daily exposure to the sun (>4 hours of sun exposure through work or daily activities) and/or frequent sunbathing/UV tanning.
- •Unwilling to discontinue applying any prescription or over the counter (OTC) topical product creams and ointments, other than makeup and moisturizers, on treatment area(s) at Baseline through their last day of study.
- •Treatment of any type of cancer within 6 months of Screening, with the exception of superficial skin cancers such as basal cell or squamous cell carcinoma outside of treatment area.
- •Known allergy to any of the Investigational product(s) or any components in the Investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
- •Unable to meet the study attendance requirements.
- •Any history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- •Participation in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
研究组 & 干预措施
SM-030 gel 0.64%
Topical application of SM-030 gel 0.64% twice daily for 12 weeks and a 4-week additional safety follow-up period.
干预措施: SM-030 gel 0.64% (Drug)
Placebo gel
Inactive comparator.
干预措施: Placebo gel (Drug)
SM-030 gel 0.08%
Topical application of SM-030 gel 0.08% twice daily for 12 weeks and a 4-week additional safety follow-up period.
干预措施: SM-030 gel 0.08% (Drug)
结局指标
主要结局
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving different SM-030 concentrations
时间窗: 12 weeks after first dose
Superiority of SM-030 gel 0.64% over SM-030 gel 0.08% based on proportion of subjects with a lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.
Change in Investigator Assessment of Global Improvement (IAGI) for subjects receiving SM-030 compared to placebo
时间窗: 12 weeks after first dose
Superiority of each Active over Placebo based on proportion of subjects with a lower Investigator Assessment of Global Improvement at Week 12 compared to Baseline. Minimum value 0 is best, or completely clear. Maximum value is 6, or worse and darker pigmentation.
次要结局
未报告次要终点