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Clinical Trials/CTRI/2023/03/050979
CTRI/2023/03/050979CompletedUnknown

To evaluate Ophthalmological safety of test product involving subjects of normal eye conditions & contact lens user on healthy female subjects

DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED0 sites33 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Unknown
Status
Completed
Sponsor
Enrollment
33
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1)Indian Female subjects.
  • •2)Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
  • •3)Between 18 and 40 years of age.
  • •4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
  • •5)Subjects having normal eye conditions & contact lens user, having habit of using face wash.

Exclusion Criteria

  • •1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
  • •2Having refused to give her assent by not signing the consent form.
  • •3Taking part in another study liable to interfere with this study.
  • •4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months).
  • •5Having a progressive asthma (either under treatment or last fit in the last 2 years)
  • •6Being epileptic.
  • •7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months).
  • •8Having cutaneous hypersensitivity.
  • •9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
  • •10Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
  • •11Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
  • •12Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
  • •13Having applied a cosmetic product (included make-up) or skin care product on the studied areas the first day of the study (only face cleaned with water is accepted).
  • •14Refusing to follow the restrictions below during the study:
  • •-Do not take part in any family planning activities leading to pregnancy and breastfeeding
  • •-Do not take part in another study liable to interfere with this study
  • •-Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
  • •-Do not change cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
  • •-During the study: Do not use other eye related and/ or eye make up than the tested products to the studied areas. (only test cleanser is accepted)
  • •-The day of the measurements: No test product or any other eye make up must be used (only face cleaned with water is accepted)
  • •15Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, A.H.A….) in the 2 weeks preceding the start of the study.
  • •16Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous 2 weeks.
  • •17Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 1 month
  • •18Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week.
  • •19Having permanent make-up on the studied area.
  • •20Having ocular problems (stye, chalazion, conjunctivitis).
  • •21Having applied a cosmetic eye product (included eye make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted).
  • •22Refusing to follow the restrictions below during the study:
  • •-Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …).
  • •-Do not have beauty treatment (e.g. skin clean

Investigators

Sponsor
DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED

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