Evaluation of comedogenicity potential of the Kojigold cream by follicular biopsy test.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Comedogensis:
研究概览
简要总结
To determine the comedogenic potential of the Kojigold cream when applied topically under occlusive conditions on the skin of human subjects. Each test material will be applied three (3) times a week for four weeks. The application will be done every alternate day, and the occlusion should be maintained for 48 hours on weekdays and 72 hours on weekend. There will be a total of twelve (12) applications. The duration of the study is approximately 4 weeks. 25 mg/cm2 of test product and control will be pipetted out on the demarked test site of 4X4 cm2 and spread uniformly. A webril pad will be applied on top of it and will be completely occluded with the micropore tape. One test site is kept as untreated control (sham control) on which an empty webril pad will be applied. Micropore tape will be used to hold the Webril pad tightly. Occlusive patches with webril pad are held securely to the skin on all sides with a porous, hypoallergenic tape
a) There will be three applications per week. Each application will be done on the test site via PDP/syringe. The test sites, each measuring 4x4cm are covered with a piece of non-absorbing cotton cloth (i.e., Curity or Webril). The patches are closely secured to the skin by occlusive tape (i.e., adhesive Blenderm or Dermalite II).
b) The procedure is repeated every alternate day until three applications per week is accomplished for a total of four weeks for occlusive conditions. Patches are removed after 48hours of exposure and once weekly after 72 hours of exposure. On removal all sites are cleaned and evaluated for any overt signs of irritation prior to repatching.
c) At the end of 4 weeks, follicular biopsy is performed at each site by placing a drop of cyanoacrylate glue on a microscope slide and holding it against the skin on the exposed site for 1 minute. The slide is gently removed from the skin, after extracting any microcomedones present at the site. Upon curing, the test slide is rapidly but accurately removed to protect the integrity of the biopsy. Slides are examined under a microscope and the number of follicles and microcomedones (if any) are counted per square cm. An optical micrometer is employed to measure the number of microcomedones and follicles to provide a tangible reference for evaluation. The counts are then totalled and averaged for comparison.Assessments
Local Intolerance Monitoring
In case of localized skin irritation, it will be recorded in the Local Intolerance form by a dermatologist.
Comedogensis:
Upon completion of the above-described counting procedure, the ratio will be calculated as.
Number of comedones/ Number of follicles.
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研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female volunteers aged 18 to 65 with no active dermatological Conditions
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
- •Subjects who have normal, dry, oily, combination (mixed) type of skin types.
- •Fitzpatrick photo type I to IV skin type
- •Willingness to participate as evidenced by voluntary written informed consent.
排除标准
- •Healthy male and female volunteers aged 18 to 65 with no active dermatological Conditions
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
- •Subjects who have normal, dry, oily, combination (mixed) type of skin types.
- •Fitzpatrick photo type I to IV skin type
- •Willingness to participate as evidenced by voluntary written informed consent Exclusion Criteria:
- •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
- •Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
- •Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory).
- •Considered immune compromised.
- •History of photosensitivity, & or diseases aggravated or triggered by ultraviolet radiation.
- •Participants with dermatographism.
- •Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- •Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
- •Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit
- •Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit.
- •Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation
- •Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication.
- •Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients including any component of the study product.
- •History of sensitization in a previous patch study
- •Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit
- •Recent history (within the last years) of alcohol or other substance abuse.
结局指标
主要结局
Comedogensis:
时间窗: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28
Upon completion of the above-described counting procedure, the ratio will be calculated as.
时间窗: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28
Number of comedones/ Number of follicles.
时间窗: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28
次要结局
- Frequency and severity of Adverse Events(Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20, Day 22, Day 24, Day 26, Day 28)
研究者
Dr Shendkar Sonal Mahadev
Skinovate Laser & Cosmetic Surgery center