The 50 Subject Human Repeat Insult Patch Test for Sensitive Skin was conducted to evaluate the irritation and sensitization potential of Yoni Wipes after repeated applications to human subjects with sensitive skin. Sponsored by Harmon Innovations in Santa Ynez, CA, the study took place at ALS Pharmaceutical, Beauty, and Personal Care in Torrance, CA, from November 12, 2024, to December 20, 2024.

Yoni Wipes, identified under Accession No. 1249390, were tested under occlusive conditions. Three boxes of samples were received on October 10, 2024, and assigned unique laboratory codes. The samples were retained for 30 days post-report unless specified otherwise by the sponsor.

A total of 82 participants were enrolled in the study, with 56 completing the full test. Participants ranged from 19 to 65 years old, comprising 47 females and 9 males, all of whom self-reported sensitive skin. Fitzpatrick Skin Types included Type 2 (burns easily, tans slightly) with 12 participants, Type 3 (moderate burns, gradual tanning) with 25 participants, and Type 4 (rarely burns, always tans) with 19 participants.

Test procedures involved applying the product to the intrascapular region using occlusive patches for nine exposures over three weeks, with each application lasting 48 to 72 hours. A rest period of 10 days was observed before a final challenge application. The scoring system, based on International Contact Dermatitis Research Group criteria, ranged from 0 (no reaction) to 4 (erythema with vesicles). Observations included monitoring for erythema, edema, papules, and vesicles.

Results indicated that all 56 completing participants exhibited no reaction (score 0). There were no product-related adverse events. However, four participants (3GZXZ, 3K4CF, 2X849, 3MNCP) experienced irritation from the adhesive tape and were discontinued from the study. Additionally, one participant (3KYNK) was discontinued due to an unrelated car accident. The negative control (DI Water) produced no reactions in any participant.

The study concluded that Yoni Wipes are non-irritating and do not cause sensitization in sensitive skin. These findings confirm the product’s suitability for individuals with sensitive skin, with no risk of irritation or allergic reaction under occlusive conditions.

For marketing purposes, Yoni Wipes can be promoted as “clinically tested” and “non-irritating for sensitive skin.” The study results can also be utilized for regulatory filings and product claims. Future testing on a larger scale may further validate these findings.

For further details or inquiries, contact Steve Park, Clinical Quality Assurance Lead at ALS Pharmaceutical, Beauty, and Personal Care in Torrance, CA, at info.bioscreen@alsglobal.com. This study was reviewed and approved by Dr. Maria Elisa Barbosa Bueno de Campos, Board-Certified Dermatologist at ALS Pharmaceutical, Beauty, and Personal Care in Torrance, CA.