A Prospective, Study Evaluating the Efficacy of DOSE Formulations in Treatment of Melasma and Cutaneous Signs of Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Improvement of Melasma
研究概览
简要总结
The primary objective is to evaluate the efficacy, of D.O.S.E formulations in the treatment of melasma and cutaneous signs of aging.
详细描述
Melasma is a hyperpigmentation disorder that presents as irregularly shaped macules on the face of women. The etiology is unknown however there is strong evidence that genetics, hormones, sun exposure can trigger and worsen the disease. Increased dermal vascularity and expression of angiogenic factors also seem to play a role. Melasma is a chronic and relapsing condition, that is difficult to treat, and can have a negative impact on quality of life.
Numerous treatments exist for melasma including topical lightening agents, chemical peels, and a variety of laser and light based options. Long-term management is difficult as topical agents can often cause irritation, burning, peeling and inflammatory hyperpigmentation. Light based therapies can also lead to relapse or worsening of the disease.
Melasma, in combination with photodamage from cumulative sun exposure and aging, can lead to a complex picture when making a skin care plan for a cosmetic patient. The custom D.O.S.E professional service can be utilized to make a personalized serum to improve skin discoloration and the visible signs of aging. The purpose of this study is to evaluate the efficacy of D.O.S.E formulations in the treatment of melasma and visible signs of aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1. Females age 18-65, Fitzpatrick skin types I-VI
- •Mild to moderate melasma
- •Half of subjects with hypervascular melasma identified by Visia complexion analysis
- •Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
- •5. Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
- •6. Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
- •7. Women of childbearing potential willing to use an acceptable form of birth control during trial period.
- •Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
- •Intrauterine coil
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- •Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
- •Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
- •8. Female patients will be either of non-childbearing potential defined as: Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12 months prior), or has had a bilateral tubal ligation at least 6 months prior to study enrollment.
排除标准
- •1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
- •2. Known hypersensitivity or allergy to the components of the study medication.
- •Concurrent enrollment in any study involving the use of investigational devices or drugs.
- •4. Current smoker or history of smoking in the last five years.
- •Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- •6. Presence of an active systemic or local skin disease that may affect treatment area.
- •7. History of the following cosmetic treatments to the area(s) to be treated:
- •Energy based device or laser procedure to the area within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
- •Medium to deep chemical peels (e.g. TCA, Phenol) for 6 months or light chemical peels (e.g. Glycolic Acid >20%) within the past 3 months;
- •History of using the following cosmetic, OTC or prescription medications:
- •a. Topical glycolic acid (5% or greater) in the past 4 weeks. b. Topical or oral tranexamic acid within in the past 4 weeks (e.g. Lytera 2.0); c. Topical Retinoids (e.g. Rx tretinoin or OTC retinol) within the past four weeks; d. Topical hydroquinone within the past 4 weeks; e. Topical salicylic acid within the past 4 weeks; f. Topical or oral corticosteroids within the past 4 weeks; g. Other topical products intended to treat melasma within the past 4 weeks;
- •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.
- •10. Any planned surgical intervention to the treatment area for the duration of the trial
- •Any visible surface alteration to the treatment area that may interfere with evaluation, at investigator discretion
- •Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion
- •Inability to comply with all study protocols and regulations
- •Current taking an immunosuppressant or applying a topical corticosteroid to the affected area
研究组 & 干预措施
Treatment
Subjects will receive dose formulation for treatment of melasma
干预措施: DOSE formulation (Other)
结局指标
主要结局
Improvement of Melasma
时间窗: Baseline to Day 120
change in Investigator MoPASI score
次要结局
未报告次要终点