Study of the Cutaneous Tolerability and Safety of V-Bath-an Intimate Hygiene Daily-use Product
Background/Objective: Several products containing various combinations of lactic acid, aloe vera, milk protein or lactoserum are commercially available, however evidence of its effectiveness in maintaining physiological pH and other subjective parameters in Indian women is lacking. Hence, to confirm the compatibility and tolerability of the intimate hygiene product V-Bath which is a combination of lactic acid, aloe vera, and milk protein when used daily, the current study was undertaken.
Method: This was a prospective, open-label, cross-over and singlecenter study in healthy female volunteers conducted under the supervision of dermatologists. The test product was V-Bath Intimate Wash and the control products were two bathing soaps to be used by an equal number of females for 7 days prior to or after crossover depending on their usage of products before participation in the study. At baseline or day 0, week 1 and week 2, each subject underwent clinical assessment for cutaneous tolerability and safety; at the same time points, subjects’ assessment was obtained using a sensory questionnaire with scores for each parameter. pH assessments were done at the same time points (Day 0, week 1 and week 2) by measuring pH before and after usage of the V-Bath and soap at the centre.
Statistical analysis used: A paired ‘T’ test with a 2-sided significance level of 5%.
Results: None of the thirty-three subjects reported erythema, itching, boils, foul smell, burning sensation, swelling, watery discharge or white/yellow discharge during the study period in response to the intervention of V-Bath or comparator soaps. There was no significant skin intolerance experienced by any of the subjects after the use of V-Bath for 7 days.
According to the analyses of the subject self-assessment records, a significant proportion of the population agreed that the product (VBath) was able to prevent odor, irritation and itchiness and provided moisturization and a soothing effect on the skin with single-use as well as regular 1-week use. The decrease in pH of the intimate area remaining from baseline (pre-wash) to the post-1-week use was significant (p=0.0230) with V-Bath unlike soap which was not found to be significant.