The objective of this study will be to evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with sensitive skin.
- Registration Number
- CTRI/2023/06/054003
- Lead Sponsor
- ITC LIMITED ITC Life Sciences and Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
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.Between 18 and 65 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
5.Specific Criteria
-Subjects representing sensitive skin type (Subjects scoring greater than 30 for Section 2- Sensitive vs Resistant skin in Dr. Baumann’s questionnaire, please refer appendix 4) and varied skin type (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
-Subjects who have not participated in a similar investigation in the past eight weeks.
1.Standard criteria
-For female: Currently established to be pregnant or actively breast feeding or has recently stopped breast feeding < 3 months.
-Having refused to give his/her assent by signing the consent form.
- Currently participating in another study that is liable to interfere with this study.
-Being diabetic.
-Being asthmatic.
-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).
- Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness.
-Subjects with cutaneous disease that could interfere with the study results.
-Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
-Having undergone surgery requiring general anesthesia of more than one hour in the past 6 months. -Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
-Having applied some product on the back thus not meeting the study requirement.
-No individual sentenced to imprisonment by a court decision or by an administrative decision, or hospitalized without consent, or admitted in a medical or social establishment.
- No minor as well as individual of age benefiting from a legal protection measure or enable to express his/her consent
2.Refusing to follow the restrictions mentioned below during the study:
- For female: Avoid pregnancy or active breastfeeding.
- Abstain from participation 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 cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
3.Specific criteria
- Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area.
-Having healing disorder in the concerned area.
-Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
-Having an allergy to perfumes and/or preservatives in cosmetic products.
-Having an allergy to plaster / adhesives used in plaster.
- Having a food allergy.
-Having a cardiovascular pathology that requires beta blocking treatments.
-Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
-Taking a retinoid-based treatment by general or oral route.
-Taking specific treatment on the back.
- Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
– Having miliaria (prickly heat) on the back.
- Presenting too many neavi on the back.
- Having high pilosity on the back.
4. Refusing to follow the restrictions below during the study:
- During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back.
- Till the follow up period of until T8 days, only water is accepted from the fir
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs & 7 days
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI