Treatment of Seborrheic Dermatitis Using a Novel Herbal-based Cream

Abstract

Objective: Seborrheic dermatitis is a common relapsing inflammatory skin condition occurring in approximately 3 to 5 percent of the general population. Current available therapies control, but do not cure seborrhea. The study's objective was to determine the safety and efficacy of a barrier-based, nonsteroidal cream incorporating herbal extracts as a treatment for facial seborrheic dermatitis. Design: Interventional, open label, safety/efficacy study. Setting: At the baseline visit, the investigator selected a target area on the face. The target area was evaluated for Investigator Static Global Assessment, desquamation (scaling), induration (inflammation), and erythema (redness) as well as self-assessed pruritus. Participants: Thirty-two subjects with seborrheic dermatitis were enrolled in the study. Measurements: Subjects were instructed to use the study medication twice a day, morning and evening, for a consecutive period of 42 days. In addition to the baseline visit (Day 0), subjects visited the clinic for two follow-up visits at Days 14 and 28 and for a final visit at Day 42. At each visit, all parameters were evaluated. Results: A reduction in all parameters evaluated was seen at almost all timepoints, improving more from one timepoint to the next during the study period. In addition, the patients expressed a high degree of satisfaction with the treatment. No adverse events were reported during this study. Conclusion: The study showed that after six weeks of treatment, the face cream provided improvement in Investigator Static Global Assessment, pruritus, desquamation, induration, and erythema. ClinicalTrials.gov Identifier: NCT02656368 (https://ichgcp.net/clinical-trials-registry/NCT02656368?term=Kamedis&rank=2).

Conflict of interest statement

Disclosure:Dr. Barak-Shinar is an employee of Kamedis Ltd., the manufacturer of Seborrheamedis Face Cream and the sponsor of this study. Dr. del Río is the Principle Investigator of the Seborrheamedis Face Cream clinical trial. Dr. Green serves on the medical advisory board for Kamedis. The study was conducted in accordance with the Declaration of Helsinki. This study was wholly funded by Kamedis Ltd.

Figures

Figures 1A and 1B.

Clinical appearance of patient with sebhorrheic dermatits (A) before and (B) after 6 weeks of treatment with a novel herbal-based cream

Figures 1A and 1B.

Clinical appearance of patient with sebhorrheic dermatits (A) before and (B) after 6 weeks of treatment with a novel herbal-based cream

Figure 2.

Average treatment score versus duration (weeks)

Figure 3.

Average pruritus self-evaluation improvement (percentage compared to BL) versus duration (weeks from BL)

Figure 4.

Response of subjects when asked how they liked the products

Figure 5.

Response of subjects when asked if they were satisfied with the speed of improvement provided by the product