Testing Skin Irritation Using Patch Test in Healthy Adults

Not yet recruiting

Conditions: Healthy individual with normal, dry, oily and combination skin type

Brief Summary: The objective of the study is to assess the dermatological safety of the test products on healthy human subjects. This will be an open-label, non-randomized, monocentric, single-application, controlled clinical trial. Healthy adult volunteers will be selected according to specific inclusion and exclusion criteria. A total of 24 healthy adult participants, both male and female, aged between 18 and 65 years in a 1:1 ratio, will be tested for irritancy of the test products intended for use on normal skin. The patch application will be evaluated based on the assessment criteria outlined in the appendices. The patch test will be carried out according to the protocol study design, Declaration of Helsinki, GCP, BIS guidelines (IS 4011:2018 Third Revision, July 2018 guidelines), ICMR guidelines and New Drugs and Clinical Trials Rules.

Recruitment & Eligibility

Inclusion Criteria

Voluntary men and women ratio of 1:1 between 18 and 65 years.
Having apparently healthy skin in test area as assessed by dermatological examination.
For whom the investigator considers that the compliance will be correct.
Subjects with normal, dry, oily and combination skin in approximately equal ratio.
The subject is informed of the need and duration of the examination and is ready to comply with protocol requirements.
Subject is ready to sign the informed consent form.
Subjects’ willingness to avoid intense UV exposure on test sites (sun or artificial UV) during the study.
Subjects’ willingness to avoid excessive water contact (e.g. swimming) or activity which causes excessive sweating (e.g. exercise, sauna) during the study.
Having valid proof of identity and age.
Volunteers evaluated Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).

Exclusion Criteria

Pregnant/nursing mothers.
Scars, acne, excessive terminal hair, or tattoos on the studied area.
Dermatological infection/pathology on level of studied area.
Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 5.
Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
Chronic illness, which may influence the outcome of the study.
Subjects on any medical treatment, either systemic or topical, which may interfere with the performance of the study treatment (presently or in the past 1 month).
Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.

Primary Outcome Measures

Name	Time	Method
1. Change from irritation potential of the test products from baseline to post application measured using the mean irritation score.	Day 2, Day 3 and Day 9
2. Score of less than or equal to 2 on the Draize scale.	Day 2, Day 3 and Day 9

Secondary Outcome Measures

Name	Time	Method
1. Incidence of treatment-emergent adverse events (safety and tolerability)	Day 2, Day 3 and Day 9

Locations (1): TrialGuna Private Limited
🇮🇳
Bangalore, KARNATAKA, India
TrialGuna Private Limited
🇮🇳Bangalore, KARNATAKA, India
Dr Nimisha Sivanandan
Principal investigator
9952088650
nimisha.sivanandan@trialguna.com