CTRI/2023/06/054033Not yet recruitingUnknown
The objective of this study will be to evaluate the sensitization potential of Skin & Hair Careformulations on healthy human subjects
Transformative Learning Solution Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Female and male Asian Indian subjects.
- •2.Healthy Human 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.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)
- •4.Photo type III to V.
- •5.Having apparently healthy skin on Test area.
- •6.For whom the Investigator considers that the compliance will be correct.
- •7.Cooperating informed of the need and duration of the examination and ready to comply with protocol procedures.
- •8.Having signed a consent form.
- •9.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •10.Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise saunaâ?¦) during the course of the study.
- •11.Should be able to read and write in English Hindi or local language.
- •12.Having valid proof of identity and age
Exclusion Criteria
- •1.For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2.Having refused to give his/her assent by not signing the consent form
- •3.Taking part in another study liable to interfere with this study
- •4.Being diabetic.
- •5.Being asthmatic.
- •6.Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •7.Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
- •8.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •9.Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
- •10.Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •11.The day of the patch application: no cosmetic product must be used (test site clean with water only).
- •12.Scars excessive terminal hair or tattoo on the studied area.
- •13.Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •14.Dermatological infection pathology on the level of studied area.
- •15.Hypersensitivity & allergy to any cosmetic product raw material or hair dye.
- •16.Any clinical significant systematic or cutaneous disease which may interfere with the study treatment or procedure.
- •17.Chronic illness which may influence the outcome of this study.
- •18.Subjects on any medical treatment either systematic or topical which may interfere with the performance of the study treatment presently or in the past one month.
- •19.Subject in an exclusion. Or participating in another food cosmetic or therapeutic trial.
- •20.Refusing to follow the restrictions below during the study: - For female: Do not become pregnant nor breastfeed - 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, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). - Do not change his/her cosmetic habit so yeah s apart from the particular conditions mentioned in the protocol, on the studied anatomic unit
Investigators
Similar Trials
Completed
Not Applicable
Evaluation of safety & Efficacy of skin care formulatioCTRI/2022/06/043455Transformative Learning Solution Pvt Ltd35
Completed
Not Applicable
Assessment of safety & Efficacy of cosmetic productCTRI/2023/02/050012Transformative Learning Solution Pvt Ltd32
Completed
Not Applicable
Evaluation of safety of productCTRI/2022/05/042477Transformative Learning Solution Pvt Ltd120
Not yet recruiting
Unknown
Assessment of safety of cosmetic productCTRI/2023/09/057658Transformative Learning Solution Pvt Ltd
Completed
Not Applicable
Evaluation of safety & Efficacy of skin care formulatioCTRI/2022/05/042747Transformative Learning Solution Pvt Ltd34