Clinical study to check skin safety in terms of skin redness, swelling, dryness due to application the test products by 24 hours patch test under complete closed application on adult healthy human subjects

Completed

• Conditions: Subjects with varied skin types (Oily, Dry, Normal and Combination)

• Registration Number: CTRI/2022/09/045995
• Lead Sponsor: Cipla Limited

Brief Summary

This is single-centre, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). Study can be

conducted in multiple groups. Safety will be assessed throughout the study by monitoring of adverse events.

Subject’s back i.e. between the scapula and waist will be utilised as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize

Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.

26 subjects in the age group of 18 to 65 years with varied skin types (Oily, Dry, Normal and Combination, preferably equal ratio) will be selected according to inclusion and exclusion criteria in the study to complete the required numbers i.e. 24 subjects at the end of the study. Preferably with an equal

number of males and non-pregnant/non-lactating females

Score the reaction, namely, erythema, dryness, wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale.

Four parameters namely erythema, dryness, wrinkles and oedema will be scored separately on irritation scoring sheet, however, the highest score of erythema, dryness and wrinkles will be taken for calculation of Mean Irritation Score (MIS).

Mean Score for Irritation = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each sample / Total no. of Subjects.

The Evaluator/Scorer will be blinded to test product assignments and any previous scores. All reasonable attempts will be made to ensure that the same individual will do scoring of all reactions to the test products during the course of the study. If the patch is reinforced with tape, any observed skin

irritation that is associated with the tape should be reported separately from that of the patch application area.

The combined mean scores and standard deviation of the 24 subjects will be calculated.

a) Positive controls i.e. 1% w/v SLS must give a combined means score of >2.0, 3% w/v SLS must give a combined mean score of greater than 3.0 and Negative control must give a combined mean score of <2. If positive control 1% w/v SLS and 3% w/v SLS give a combined means score less

than 2.0 and 3.0 respectively and/ or negative control give a combined mean score more than 2.0, then the test need to be repeated on another newly recruited volunteer’s.

b) A combined mean score of up to 2.0/8.0 will mean that product is ‘Non-Irritant’.

c) Usage of cosmetic product with a score up to 4.0/8.0 which is ‘Mildly Irritating’ may be reviewed by manufacturer for safety of the formulation.

d) No cosmetic product should be marketed which has an irritation score above 4.0/8.0. This product should be considered as an ‘Irritant’.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-12
• Study Start: 2022-05-10
• Study Completion: 2022-10-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Age: 18-65 years (both inclusive) at the time of consent.
• Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
• Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
• Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
• Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
• The subject is in good general health as determined by the Investigator on the basis of medical history.
• Subjects are willing to maintain the test patches in designated positions for 24 Hours.
• Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instructions given.

Exclusion Criteria

• Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
• Medication which may affect skin response and/or past medical history.
• Subject having history of diabetes 4.
• Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
• Subject suffering from any active clinically significant skin diseases which may contraindicate.
• Participation in any patch test for irritation or sensitization within the last four weeks.
• Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
• Use of any: i.
• Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
• Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
• Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted) 10.
• Topical drugs used at application site.
• Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
• Individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
• Subject with known allergy or sensitization to medical adhesives, bandages.
• Participation in other patch study simultaneously.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of the test	Irritation Scoring at 30 mins and 24 hours post | patch removal. Scoring can be done at 168 | hours post-patch removal if needed.
products by 24 Hours Patch Test Under	Irritation Scoring at 30 mins and 24 hours post | patch removal. Scoring can be done at 168 | hours post-patch removal if needed.
Complete Occlusion on healthy adult human	Irritation Scoring at 30 mins and 24 hours post | patch removal. Scoring can be done at 168 | hours post-patch removal if needed.
subjects and adequate representation of varied	Irritation Scoring at 30 mins and 24 hours post | patch removal. Scoring can be done at 168 | hours post-patch removal if needed.
skin types (Oily, Dry, Normal and Combination)	Irritation Scoring at 30 mins and 24 hours post | patch removal. Scoring can be done at 168 | hours post-patch removal if needed.

Secondary Outcome Measures

Name	Time	Method
Safety of the skin	At 30 mins and 24 hours post patch removal. Scoring can be done at 168 hours post-patch removal if needed

Trial Locations

Locations (1)

NovoBliss Research Private Limited; 🇮🇳 Gandhinagar, GUJARAT, India

NovoBliss Research Private Limited

🇮🇳Gandhinagar, GUJARAT, India

Dr Nayan Patel

Principal investigator

91-9909013286

dr.nayan@novobliss.in