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Clinical Trials/CTRI/2020/03/023845
CTRI/2020/03/023845
Completed
Phase 1

A study to evaluate the efficacy of test product for anti-ageing benefits and reduction of spots in healthy female subjects - None

Impres Health Pvt Ltd0 sites37 target enrollmentTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Impres Health Pvt Ltd
Enrollment
37
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
November 24, 2020
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Impres Health Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • 1\.Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
  • 2\.Subjects in the age group of 30\-50 years (both ages inclusive).
  • 3\.Subject with Fitzpatrick skin types III to V
  • 4\.Each subject should have hyperpigmentary regions (may include mild melasma or at least one spot of 3mm size)
  • 5\.Subjects having visible fine lines and wrinkles in periorbital area (Crowââ?¬•s feet\-under eye) \& forehead.
  • 6\.Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
  • 7\.Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
  • 8\.Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
  • 9\.Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
  • 10\.Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow\-up.

Exclusion Criteria

  • 1\.Subject with any other signs of significant local irritation or skin disease.
  • 2\.Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
  • 3\.Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
  • 4\.Subjects who do not agree to remove all jewelry on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA imaging.
  • 5\.Subjects having hair style which covers almost the entire forehead
  • 6\.Subjects undergoing any treatment of any skin condition on their face/forearm.
  • 7\.Subjects not willing to discontinue other topical facial products.
  • 8\.Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
  • 9\.Pregnant women (as confirmed by UPT) and lactating women
  • 10\.Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.

Outcomes

Primary Outcomes

Not specified

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