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临床试验/CTRI/2025/09/094638
CTRI/2025/09/094638尚未招募Unknown

An open-label clinical study to check the efficacy of 1% Hyaluronic Sunscreen Aqua Gel on hydration, plumper-looking skin, and reduction in skin dryness in healthy volunteers

THE DERMA CO.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9月23日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
1. change in skin hydration

研究概览

简要总结

An Open Label clinical study within subject pre-post application Assessments

Test Area- face,  No of volunteers- 36

Age- 18-55years

Assessments:

  1. Corneometer- for hydration

  2. DSLR imaging- full face and closer with plumer skin imaging

  3. Clinical and visual assessments

  4. Dermatologist visual grading 0-3 scale

  5. Subjective and Sensory Assessments

  6. Immediate sensory Questionnaire

Dose and application- Adequate amount applied uniformly on face

Time Points:  0min, 30min, 2hrs and 8hrs

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)

入选标准

  • Gender: Non-pregnant, non-lactating female Age 18–55 years.
  • Subject willing to give written informed consent
  • Women of child bearing potential must have a negative urine pregnancy test
  • Fitzpatrick skin type II–V.
  • Healthy skin on test areas.
  • Agree to avoid other facial actives 7 days prior to visit.

排除标准

  • Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
  • Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
  • Have open sore or open lesions in the treatment area
  • Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
  • Have participated in any interventional clinical trial in the previous 30 days.
  • Known allergy to product ingredients.
  • Active dermatitis, wounds or lesions on test areas.
  • Facial procedures in prior 4 weeks (e.g., peels, lasers).

结局指标

主要结局

1. change in skin hydration

时间窗: At T0, 30 minutes, 2 hour and 8 hours

2. DSLR Imaging

时间窗: At T0, 30 minutes, 2 hour and 8 hours

3. Dermatologist visual grading

时间窗: At T0, 30 minutes, 2 hour and 8 hours

次要结局

  • 1. SGA(At T0, 30 minutes, 2 hour and 8 hours)

研究者

发起方
THE DERMA CO.
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Robin chugh

CCFT Laboratories

研究点 (1)

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