INTRODUCTION
Atopical botanical complex from a novel combination of phytochemicals, denoted as herbal anti-inflammatory treatment 1 (HAT1), was developed for topical treatment of psoriasis. HAT1 is a US Food and Drug Administration compliant over-the-counter product that contain extracts of the following: Achillea millefolium, Aesculus hippocastanum, Althaea officinalis, Avena sativa, Berberis vulgaris, Conium maculatum, Cochlearia officinalis, Ervum lens, Hamamelis virginiana, Hydrastis canadensis, Malva sylvestris, Matricaria chamomilla, Nasturtium officinale, Phytolacca decandra, Pimpinella saxifrage, Populus alba, Populus tremuloides, Rhus toxicodendron, Sanguinaria Canadensis, Sambucus nigra, Scophularia nodosa, Smilax medica, Tussilago farfara, Veronica officinalis, and Vincetoxicum officinale. Mechanism of HAT1 is under investigation, but preliminary in vitro data of primary human keratinocytes demonstrated downregulation of IL-17A/ TNF-α–induced IL-8 release.1 Previous studies demonstrated superior efficacy of HAT1 compared to calcipotriol in achieving PASI (Psoriasis Area and Severity Index) 75 and reducing the Physician’s Global Assessment (PGA) score to a clear or minimal response.2
An investigator-initiated, open-label study was conducted to evaluate efficacy and tolerability of topical HAT1 in adult patients with mild plaque psoriasis. The institutional review board approved the study and written informed consent was obtained. Eleven patients (4 males, mean age = 55.7) with body surface area (BSA) of 3 to 10% were enrolled (mean PASI = 4.5). Five patients were on a stable dose of systemic therapy, including apremilast (2), secukinumab (2), and ustekinumab (1). Patients applied HAT1 twice daily to active lesions and assessed every 4 weeks from baseline (week 0) to week 12.
The primary endpoint was the mean percent improvement from baseline in the product of the static PGA (sPGA) and BSA (sPGAxBSA) at week 12. sPGA>SPGA was used as it is a sensitive measurement of psoriasis severity compared to PASI in patients with mild disease.3 Modified Intention-totreat analysis (ITT) was used to include subjects who received at least 1 application of HAT1 and at least 1 post-baseline assessment. Last observation carried forward method was used for any missing data. Secondary endpoint was the percentage improvement in the Dermatology Life Quality Index (DLQI). Other parameters include percentage improvement of the Numerical Rating Scale for Itch (NRS), BSA, and PASI. One patient was excluded for the DLQI analysis due to a protocol deviation at baseline.
Nine patients completed the study. One patient was lost to
_for_Treating_Psoriasis_An_Investigator_Initiated_Open_Label_Study_Figure1)
An investigator-initiated, open-label study was conducted to evaluate efficacy and tolerability of topical HAT1 in adult patients with mild plaque psoriasis. The institutional review board approved the study and written informed consent was obtained. Eleven patients (4 males, mean age = 55.7) with body surface area (BSA) of 3 to 10% were enrolled (mean PASI = 4.5). Five patients were on a stable dose of systemic therapy, including apremilast (2), secukinumab (2), and ustekinumab (1). Patients applied HAT1 twice daily to active lesions and assessed every 4 weeks from baseline (week 0) to week 12.
The primary endpoint was the mean percent improvement from baseline in the product of the static PGA (sPGA) and BSA (sPGAxBSA) at week 12. sPGA>SPGA was used as it is a sensitive measurement of psoriasis severity compared to PASI in patients with mild disease.3 Modified Intention-totreat analysis (ITT) was used to include subjects who received at least 1 application of HAT1 and at least 1 post-baseline assessment. Last observation carried forward method was used for any missing data. Secondary endpoint was the percentage improvement in the Dermatology Life Quality Index (DLQI). Other parameters include percentage improvement of the Numerical Rating Scale for Itch (NRS), BSA, and PASI. One patient was excluded for the DLQI analysis due to a protocol deviation at baseline.
Nine patients completed the study. One patient was lost to
