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Clinical Trials/CTRI/2022/01/039627
CTRI/2022/01/039627
Completed
未知

Efficacy Evaluation of Cosmetic Formulations in Conferring Anti-Skin Ageing Benefits in Healthy Human Volunteers

ITC Life Sciences Technology Centre0 sites151 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
ITC Life Sciences Technology Centre
Enrollment
151
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
June 3, 2022
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
ITC Life Sciences Technology Centre

Eligibility Criteria

Inclusion Criteria

  • 1\.Subject is willing to give a written informed consent and come for regular observations.
  • 2\.Subject is a healthy adult (male or female), in the age range of 35 and 60 years.
  • 3\.Subject identified for Wrinkles, has at least 2 and preferably \>4\-5 prominent wrinkles on crow feet area, forehead, undereye, Throat/ Neck and DÃ?©colletage.
  • 4\.Subject identified for Post Inflammatory Hyperpigmentation (Dark Spots), has at least 2 and preferably \>4\-5 hyper pigmentary spots on face that are freckles / age spots/ post inflammatory hyperpigmentation spots like post acne marks/ Seborrheic dermatitis/ or marks other than melasma/ chloasma or nevi.
  • 5\.Atleast 20 subjects in each treatment group with prominent Undereye dark circles
  • 6\.Atleast 20 subjects in each treatment group with sagging skin under the chin, throat,
  • 7\.Subject has not participated in a similar clinical investigation in the past three months.
  • 8\.Subject has not used any topical fairness product on face or undergone a treatment such as facials, packs, bleaching etc on face since the last 2 weeks. In case of having used fairness product in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.
  • 9\.Subject is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs etc either at home or at parlour during the entire study duration.
  • 10\.Subject with no skin sensitivity symptoms to the investigational product during the skin sensitivity test.

Exclusion Criteria

  • 1\.Subject with a known history or present condition of allergic response to any cosmetic/pharmaceutical products, toiletries or their ingredients including fragrance.
  • 2\.Subject who has used any systemic medication (antibiotics, oral contraceptive pills, retinoids, steroids, spironolactone or any anti acne medication) within past 4 weeks or any topical facial medication within 2 weeks before the start of the study, which could compromise the study.
  • 3\.Subject with a medical history of disease or condition or a concurrent illness or pre\-existing or dormant dermatologic condition (psoriasis, rosacea, rashes, eczema etc.) that could interfere with the study results.
  • 4\.Subject with excessive facial hair or scars, which could interfere with evaluation.
  • 5\.Subject with a history of having used a similar product, less than 1 week prior to the scheduled study commencement.
  • 6\.Subject who is currently pregnant (as confirmed by the urine pregnancy test) or nursing or contemplating pregnancy during the study course.
  • 7\.Subjects viewed by the investigator as not being able to complete the study.

Outcomes

Primary Outcomes

Not specified

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