Patch test on Healthy subjects
- Registration Number
- CTRI/2022/03/041220
- Lead Sponsor
- Glance Collective Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Subjects with Fitzpatrick skin type III (medium brown European) to V (middle-east type, Indian,Amerindian) (Refer Annexure â??IV).
2.Healthy adult human volunteers aged 18 â?? 55 years (both ages inclusive). Subjects willing to submit proof of identity [a copy of the valid photo identity (ID) cards provided by the government body or employers] and date of birth (DOB) for age confirmation/eligibility to participate in the trial.
3.Healthy adult male and female subjects.
4.Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study
5.Subjects with normal outcome of the medical history within last 04 weeks prior to start of the study.
6.Non pregnant women and non lactating mothers.
7.Urine pregnancy test to the performed for confirmation in females.
8.Subjects able to communicate effectively.
9.Willingness to avoid intense UV exposure on test site ( sun or artificial UV), during the course of the study.
10.Willingness to avoid water contact (i.e. swimming)or activity which cause sweating (i.e. exercise, sauna,etc.) during the course of the study.
11.Ready to wear loose cotton clothes.
12.Subjects who ate capable of understanding and having signed the informed consent form after detailed description of the treatment procedures, benefits and potential risks, if any.
13.In the judgment of the principal investigator (PI), able to comply with protocol requirements.
1.Subjects having known hypersensitivity to the study product or its constituents
2.Subjects having clinically significant active dermatitis or skin disease(s) anywhere in the body.
3.People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking and exercising, etc.)
4.Current use of immunosuppressive drugs and/or organ transplant.
5.Current use of any topical or systemic drug that could interfere with the study treatments/assessments,(corticosteroids,anti-inflammatory drugs, antihistamines, retinoids) within the last 4 weeks prior to participation in the study.
6.Any significant medical condition which, in the investigatorsâ??sjudgements, could interfere with subjetsâ??s participation in the study (asthma, insulin-dependent diabetes, malignancy, autoimmune diseases,etc.)
7.Any concomitant medications that in the investigatorâ??s judgment can confound or alter test results or evaluation of adverse events.
8. Pregnant and lactating females
9.Vaccination during three weeks preceding the study or intended during the course of the study.
10.Subjects who would not fit into inclusion criteria.
11.Subjects with past history of contact dermatitis.
12.Subjects who would not give consent for study participation
13.Subjects not willing to submit proof of identity and Date of birth in the form of a copy of valid photo ID proof/card(s)
Specific criteria:
1.Having eczema, psoriasis, lichen plan, vitiligowhatever the considered area be.
2.Having disorder of the healing (whatever the considered area)
3.Having rhinitis, allergic conjunctivitis or rhino sinusitis.
4.Having allergy to perfumes and/or preservatives in cosmetic products.
5.Having allergy to plaster/cotton bandage.
6.Having food allergy.
7.Having cardiovascular pathology (taking beta blockers).
8.Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
9.Taking a retinoid based treatment by general or oral route.
10.Taking specific treatment- Inter scapular (between the shoulder blades) or on the inner left or right arm.
11.Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
12.Having miliaria (prickly heat) on the site of application.
13.Presenting too many naevus on the site of application.
14.Having high pilosity on the site of application.
15.Refusing to follow the restrictions below during the study:
Instructions to the subjects (to be followed strictly)
1.During the first 24 hours (after patch application), neither cosmetic products nor water must be applied anywhere near nor on the site of LP application.
2.Till the follow up period of until T8 days, only water is accepted for cleaning from the first reading i.e. T2 days (24 hours after the patch removal).
3.Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches).
Do not expose the application site to the sun.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety on dermal patch tests for all the productsTimepoint: 0hour,24Hours,48hours and 7days post patch removal
- Secondary Outcome Measures
Name Time Method Reporting Adverse EventsTimepoint: 0hour,24 Hours,48 hours and 7days post patch removal