A Prospective, Randomized, Open-label Study Evaluating the Efficacy of a Nanodiamond Periprocedural Skin Care Regimen for Ablative Resurfacing
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 主要终点
- Investigator Evaluation of Erythema, Edema, Exudation and Crusting
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and tolerability of Pavise Extracellular Matrix Restore (ECMR), compared with standard acute post-operative care, when used as the primary occlusive treatment immediately following ablative CO₂ and Er:YAG facial laser resurfacing to support wound healing.
详细描述
8 patients total will receive an ablative CO₂ and Er:YAG facial laser resurfacing treatment to the face. Each will be assigned to either Group A Control or Group B Active and given a skincare regimen to follow post procedure. Patients will return for follow up visits at Day 1 post procedure, Day 4 post procedure, Day 7 post procedure, 14 days post procedure and 3 months post procedure for 2D photography and assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females in good general health age 35-70 years of age.
- •Subjects with score Moderate to Severe (Class II-III, Score 4-9) on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale (Appendix E)
- •Subjects with score Moderate to Severe facial photodamage as assessed by the Modified Griffth's Scale (Appendix F)
- •Fitzpatrick skin types I-III.
- •Must be willing to give and sign Informed Consent Form, Photography Release Form and HIPAA Form.
- •The subject must be planning to undergo ablative CO2 and Er:YAG laser resurfacing to the face and willing to comply with study dosing and complete the entire course of the study.
- •Subjects using any skin care products (per physician-investigator discretion) must discontinue use of these products 14 days before treatment and throughout the duration of the study. Subjects will only use the products they are instructed to use by the investigator.
- •Male subjects with facial hair must be willing to shave the morning of the procedure
- •Female patients will be either of non-childbearing potential defined as: Having no uterus or no menses for at least 12 months. Women of childbearing potential must agree to use an effective method of birth control during the study, such as:
- •Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
- •Intrauterine coil
- •Bilateral tubal ligation
- •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 (4) if becomes sexually active).
- •Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with an Un-Vasectomized partner).
- •Negative urine pregnancy test results at Baseline prior to procedure (if applicable
排除标准
- •Pregnant, planning to become pregnant during the course of the study, or breastfeeding.
- •Prescence of an active bacterial, fungal, or viral infection in the treatment area.
- •Significant history or current evidence of a medical, psychological or other condition that, in the investigator's opinion, would preclude enrollment into the study.
- •Use of any topical products containing tretinoins or derivatives, alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the face within 14 days prior to or during the study period, other than the study products.
- •Receipt of a chemical peel, any systemic steroids, a non-ablative laser, ablative laser, microfocused ultrasound, light or radio frequency treatment, deep chemical peel, or dermabrasion on their face within 6 months prior to study enrollment.
- •Receipt of a microdermabrasion (light or medium skin peel) treatment to the face within 30 days prior to enrollment and unwillingness to refrain from use for the duration of the study period.
- •Excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study or has used self-tanner within 7 days prior to enrollment.
- •Prior treatment with a systemic retinoid within the past 3 months (e.g., Accutane®, Roche Dermatologics).
- •History of keloids or hypertrophic scars.
- •Known allergy to Valacyclovir or Fluconazole or sensitivities to benzocaine, lidocaine, tetracaine, PABA (para-amino benzoic acid), or other local anesthetics of the amide or ester family sedation medication.
- •Presence of tattoo and/or scar in the treatment area that in the investigator's opinion would interfere with study assessments.
- •History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the physician-investigator
- •Inability to comply with all study protocol restrictions and visits.
- •Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
- •History of non-compliance with clinical research protocols.
研究组 & 干预措施
Group A
4 participants will undergo an ablative CO₂ and Er:YAG facial laser resurfacing treatment and receive Pavise ECMR (extracellular matrix restore) serum for post treatment care.
干预措施: Pavise Serum (Drug)
Group A
4 participants will undergo an ablative CO₂ and Er:YAG facial laser resurfacing treatment and receive Pavise ECMR (extracellular matrix restore) serum for post treatment care.
干预措施: Co2/Er:YAG (Device)
Group B
4 participants will undergo an ablative CO₂ and Er:YAG facial laser resurfacing treatment and receive vehicle serum for post treatment care.
干预措施: Sham Comparator (Drug)
Group B
4 participants will undergo an ablative CO₂ and Er:YAG facial laser resurfacing treatment and receive vehicle serum for post treatment care.
干预措施: Co2/Er:YAG (Device)
结局指标
主要结局
Investigator Evaluation of Erythema, Edema, Exudation and Crusting
时间窗: Day of procedure, post day 1, post day 4, post day 7, post day 14
Circle one for Perioral Area: Erythema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Edema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Crusting: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Exudation: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Circle one for Periorbital Area: Erythema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Edema: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Crusting: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe Exudation: 0= None 1. Mild 2. Moderate 3. Pronounced 4. Severe
次要结局
- Subject Self Assessment Questionnaire(Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit)
- Fitzpatrick Goldman Classification of Wrinkling and Degree of Elastosis Scale(Screening, Baseline, 3 month visit)
- Tolerability Assessment by the Investigator(Day of procedure, post day 1, post day 4, post day 7, post day 14, 3 month visit)
- Subject Healing Questionnaire(post day 1, post day 4, post day 7, post day 14)
- Subject End of Study Self Assessment Questionnaire(3 month visit)
- Investigator Global Improvement Assessment(3 month visit)