Amino acids found in the outermost layers of the skin are crucial to normal skin hydration and are derived from degradation of the protein filaggrin. Filaggrin mutations or suppressed filaggrin production due to inflammation can result in lack of amino acids and dry skin.
MC2 Therapeutics recently sponsored a 21-day study conducted by Dr. Christian Avnstorp at the Skin Clinic in Rødovre, Denmark (Hudklinikken i Rødovre). The study investigated and measured the efficacy of biomeeTM Dry Skin while investigating the cream’s tolerability and the subjects’ subjective assessment of the cream.
The Study
60 adult patients participated in the open-label study, which means that both the participants and the researcher were aware that biomeeTM Dry Skin was being administered. All of the participants suffered from dry skin, with atopic dermatitis, ichthyosis vulgaris, and hand eczema being the most frequent diagnoses within the test group.
The study evaluated the cream’s hydration properties and its ability to alleviate dryness, scales and itching over the course of 21 days. The cream was applied twice daily to an area of the body with dry skin (2% of the total body surface area). The researcher scored its effect on three symptoms of dry skin:
– Dryness
– Scales
– Scratch marks
The scoring was based on a scale of 0–3 for each parameter (with 0 being no symptoms). Scores were recorded on Day 1 (baseline), Day 7, and Day 21.
The Results
54 participants finished the study. Of these, 47 (87%) were classified as “treatment success” on Day 21. “Treatment success” was defined as “improvement in at least two of the three symptoms of dry skin.”
Adverse events to the cream were minor, and 77% of the participants found the cream to be “pleasant” or “very pleasant” after application.
Dryness, Scaling & Scratch Marks
The graph below presents the average (i.e., mean) scores of dryness, scaling, and scratch marks on Day 1, Day 7, and Day 21. Each of the symptoms was evaluated on a scale of 0–3.
The data shows that dryness, scaling, and scratch marks were notably reduced on Day 21.
*p<0.0001, **p=0.0007.
The following photos show a 20-year-old male with atopic dermatitis on Day 1 and Day 21 of the study. Informed consent to publish the pictures has been obtained from the patient.
The following photos show a 56-year-old woman with ichthyosis vulgaris on the lower leg on Day 1 and Day 21 of the study. Informed consent to publish pictures has been obtained from the patient.
Itch Intensity & Sleep Disturbances
Of the 54 patients who completed the study, 45 self-reported itching while 16 also self-reported sleep disturbances. Sleep disturbances were found to be closely associated with itching. Patients who reported sleep disturbances also reported a higher average itch intensity vs. those who didn’t.
The graph below presents the average (i.e., mean) scores of itch intensity and sleep disturbances on Day 1, Day 7, and Day 21. Patients self-evaluated each symptom on a scale of 0–10, with “0” representing no symptoms and “10” representing the worst possible symptoms.
The data shows that itch intensity and sleep disturbances were notably reduced on Day 21.
Study Conclusions
The study found biomeeTM Dry Skin to be highly effective in alleviating symptoms of dry scaling skin, itching, and related sleep disturbances. The cream was very well accepted by patients and was found to improve their quality of life.
