Study on the use of palmarosa essential oil in scalp inflammation

INTERVENTION: Participants will be randomized into an intervention group that will perform daily topical application of a solution containing palmarosa essential oil (at a concentration to be defined according to prior safety data), and a control group that will perform daily topical application of a carrier without essential oil, the treatment duration will be si Xweeks, the palmarosa essential oil and hazelnut vegetable oil from the brand Grandha (Brazil) will be used, to avoid biased perception by the researcher or the volunteer, the palmarosa fragrance will be added only for placebo effect, since this is a randomized double‐blind clinical trial, the fragrance will be synthetic, and therefore will not contain volatile substances with biological effects such as those present in essential oils, exerting only the effect of olfactory memory of the corresponding plant, benefiting its placebo effect in the study, the fragrance for use in the control group will be purchased from a fragrance house; the sample will be prepared by mixing two hundred mL of hazelnut vegetable oil and one hundred drops of palmarosa essential oil in a glass beaker, maintaining a concentration of two point forty‐four percent (considered safe according to the literature) and, immediately after homogenization, it will be quickly fractionated (to minimize volatilization) into thirty mL amber glass dropper bottles, for the control group, a mixture of hazelnut vegetable oil with fragrance will be prepared to give the same color, smell and texture as the first, also fractionated into thirty mL amber glass dropper bottles CONDITION: L30.9 Seborrheic dermatitis of the scalp; scalp psoriasis ; Unspecified dermatitis of the scalp PRIMARY OUTCOME: For a probabilistic approach to adverse event detection, the fourteen volunteers will be evaluated via photographic and trichoscopic documentation, as well as self‐reported clinical data, before and after the product usage period; the expected outcome for phase one (a safety assessment phase involving healthy volunteers) is the absence of adverse events and high dermatological tolerability in both the intervention and control groups SECONDARY OUTCOME: The primary outcome is the reduction in scalp inflammation, measured using a standardized four‐point clinical scale (zero equals no inflammation; three equals intense inflammation); a minimum clinically relevant difference of one point on the inflammation scale was considered; in the absence of prior specific data on the variability of this difference, a conservative estimate of the standard deviation of differences equal to one point was adopted, a common value for short clinical scales with good reproducibility; a significance level of five percent (alpha equal to five hundredths) and a statistical power of ninety‐five percent were adopted INCLUSION CRITERIA: Volunteers who present clinical signs of inflammation on the scalp (erythema, pruritus, desquamation or sensitivity identified with the aid of trichoscopy); aged between eighteen and sixty‐five years; of both sexes; who agree to participate by signing the informed consent form will be studied