Objective

The objective of the Human Repeat Insult Patch Test (hRIPT) was to evaluate GuruNanda® Mouth Tape, for the potential to induce primary or cumulative dermal irritation and/or allergic contact sensitization through repetitive epidermal contact under controlled clinical test conditions.

Method

The study was conducted by Repeated Insult Patch Test using a panel of qualified male and female participants. The upper back between the scapulae served as the treatment area. During the induction phase, patches were applied three times per week for a total of nine applications. After the induction phase, and following a rest period of at least ten days, a challenge patch was applied to a virgin test site adjacent to the original induction site. The challenge site was evaluated on clinic Day 1 and Day 3 after application. Skin responses were scored using the study evaluation scale, where 0 indicated no visible skin reaction and increasing numerical values indicated greater erythema severity. Additional dermal sequelae, if present, were recorded using the study letter-code system.

Data and Results

The study enrolled 111 qualified subjects, male and female, ranging in age from 22 to 70 years. A total of 105 subjects completed the clinical trial. The report states that observations remained negative throughout the test interval. No adverse events were reported, and no amendments were made.

Conclusion

Under the conditions of this clinical trial, GuruNanda® Mouth Tape, indicated no potential for dermal irritation or allergic contact sensitization. The results support the skin compatibility of the product under the repeated patch-test conditions used in the study.