A Randomized, Evaluator-blind, Single-center and Two-arm Clinical Study Designed to Evaluate the Local Tolerance and Cosmetic Efficacy of a Topical Skin Care Formulation in Healthy Female Subjects With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a 70% Glycolic Acid Facial Peel Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores
研究概览
简要总结
To evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in healthy female participants with mild to advanced photo-damaged facial skin who have undergone a 70% Glycolic Acid facial peel procedure.
详细描述
This will be a randomized, evaluator-blind, single-center and two-arm clinical study designed to evaluate the local tolerance and cosmetic efficacy of a topical skin care formulation in healthy female participants with mild to advanced photo-damaged facial skin who have undergone a 70% Glycolic Acid facial peel procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Females aged between 30 and 60 years inclusive.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- •Willingness to actively participate in the study and to attend all scheduled visits.
- •Skin Type: Fitzpatrick phototype II-IV and participants with Glogau photoaging type II-III
- •Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) or male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant.
排除标准
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Women who are breast-feeding.
- •a) Active skin disease or open wound in the test area, b) Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, Clindamycin, isotretinoin) within the last 24 months, c)Medical history of dysplastic nevi or melanoma, d) Preexisting inflammatory dermatoses such as psoriasis, atopic dermatitis, e) Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could, in the opinion of the investigator, influence the investigation, f) Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines within 7 days prior to screening and/or throughout the entire course of the study, g) Systemic use of over-the-counter (OTC) analgesics or anti-inflammatory drugs 24 hours prior to screening. h)Systemic use of any photosensitizing medication 2 weeks prior to screening, i) Intense sun exposure, UV-treatments or tanning salon visit within two weeks prior to screening, j) One of the following illnesses that might require regular systemic medication; Insulin-dependent diabetes, cancer, k) One of the following illnesses if not medicated: Asthma, hypertension, l) Medical history of abnormal response to sunlight, m) Participant's with a history of mental illness, n) Ocular surgery within the last 12 months.
- •o) Ocular trauma, infection or inflammation within the last 3 months, p) Active blepharitis, conjunctivitis, uveitis, q) Any ocular pathology requiring topical ocular treatment within the last 1 month, r) Ocular laser within the last 3 months, s) Aesthetic, cosmetic or dermatological treatment in the treatment area (face), including the use of skin tone lightning products, within the last 3 months, t) Use of facial scrubs, depilatory creams, waxing and/or bleaching within the last 2 weeks prior to screening, u) Microdermabrasion and/or laser hair removal within the last 4 weeks prior to screening, v) Medical history of Herpes Simplex (Cold Sores).
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients and documented allergies to cosmetic products or study ingredients.
- •Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study.
- •Recent history (within the last 5 years) of alcohol or other substance abuse.
- •An employee of the sponsor or the study site or members of their immediate family.
- •Required to work outside during daylight hours over the duration of the study and required or otherwise intending to spend prolonged periods of time outside during daylight hours over the duration of the study (e.g. holiday, sunbathing, and gardening).
- •A score of "Severe" for any Dermatologist or Participant's Self-Assessed endpoint at any time for the study material sensitivity test.
研究组 & 干预措施
Group 1
Participants will apply a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips and will apply twice daily (morning and evening) to the full face after cleansing. All participants will be instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
干预措施: Test Product (Other)
Group 1
Participants will apply a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips and will apply twice daily (morning and evening) to the full face after cleansing. All participants will be instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
干预措施: Cleanser (Other)
Group 1
Participants will apply a pea-sized quantity of test product (approximately 0.6-1 grams (g)) topically onto the fingertips and will apply twice daily (morning and evening) to the full face after cleansing. All participants will be instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime.
干预措施: Sunscreen (Other)
Group 2
Participants will wet face with water and work a small amount of facial cleanser (approximately 0.6-1 g) into lather. Massage topically onto wet skin and rinse with water twice daily (morning and evening). After cleansing, participants will apply a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
干预措施: Cleanser (Other)
Group 2
Participants will wet face with water and work a small amount of facial cleanser (approximately 0.6-1 g) into lather. Massage topically onto wet skin and rinse with water twice daily (morning and evening). After cleansing, participants will apply a pea-sized quantity (approximately 0.6-1 g) of the sunscreen in the morning and at lunchtime.
干预措施: Sunscreen (Other)
结局指标
主要结局
Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores
时间窗: 14 days after completion of the facial peel procedure
The dermatologist assessed the local tolerance of the post-procedure skin care regimen in context of the expected effects of the procedure for each participant using the scale as below: 0 - Product regimen was well tolerated, 1 - product regimen was not well tolerated. The dermatologist observed on the total set of clinical and participant self-assessment data for each participant. Lower scale value implies that no clinically significant worsening of the expected signs/symptoms of the procedure, no new signs/symptoms manifest during product use. Whereas, higher scale value implies clear, clinically relevant worsening of the severity or frequency of expected signs/symptoms of the procedure and/or any occurrence of new, unexpected signs/symptoms during product use.
次要结局
- Change From Baseline in Participant Self-assessment Scores for Tightness(14 days after completion of the facial peel procedure)
- Change From Baseline in Total Score of Dermatologist Assessments(14 days after completion of the facial peel procedure)
- Change From Baseline in Sum of Participant Self-assessment Scores for Redness, Pain, Stinging/Burning, Itching, Tightness and Dryness(14 days after completion of the facial peel procedure)
- Change From Baseline in Participant Self-assessment Scores for Redness(14 days after completion of the facial peel procedure)
- Change From Baseline in Instrumental Measurement of Barrier Function Using Tewameter(14 days after completion of the facial peel procedure)
- Change From Baseline in Instrumental Measurement of Moisturisation Using Corneometer(14 days after completion of the facial peel procedure)
- Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness(14 days after completion of the facial peel procedure)
- Change From Baseline in Participant Self-assessment Scores for Pain(14 days after completion of the facial peel procedure)
- Change From Baseline in Participant Self-assessment Scores for Itching(14 days after completion of the facial peel procedure)
- Change From Baseline in Participant Self-assessment Scores for Stinging/Burning(14 days after completion of the facial peel procedure)
- Change From Baseline in Participant Self-assessment Scores for Dryness(14 days after completion of the facial peel procedure)
- Global Self-assessment of Participants(14 days after completion of the facial peel procedure)