As patients continue to ask about OTC products to help alleviate skin conditions diagnosed by their dermatology clinician, it is essential to understand those products’ ingredients and roles in a treatment regimen. Research conducted by the editor in chief of Dermatology Times shows the value of understanding an OTC product’s ingredients to best advise patients. In this case, she looked at an easily accessible option for patients with psoriasis.
“The purpose of the study was to look at an OTC product that could be used for very minor psoriasis,” said Zoe Diana Draelos, MD, research and clinical board-certified dermatologist and consulting professor at Duke University in High Point, North Carolina. “It can be used as an adjunct to topical prescription therapy where a little bit of extra oomph is needed to alleviate the disease, or it could also be used in conjunction with injectable biologics.”
Key Takeaways
- Study results demonstrated a statistically significant reduction in psoriasis severity over the 12-week study period.
- The key ingredients in this study were salicylic acid (a keratolytic agent), turmeric (rich in anti-inflammatories and antioxidants), and shea butter (a stable moisturizing ingredient high in bioactive triterpene esters).
- This OTC product can serve as a monotherapy or as a supplement to other psoriasis treatment regimens
- While the study showed promising results, it had some limitations, including the absence of a placebo comparison group and a relatively small sample size.
Study Development
Draelos developed the study to examine the efficacy and tolerability of a once-daily 3% salicylic acid treatment gel containing turmeric, a low concentration of salicylic acid, and shea butter exfoliating moisturizer in the management of psoriasis flare-ups, either as a monotherapy or as a supplement to other psoriasis treatment regimens.
She tested the regimen among men and women 18 years and older (n=20) with Fitzpatrick skin types I to VI. Participants had diagnoses of visible mild to moderate psoriasis of a body surface area of less than 10% as their only dermatological disorder to be able to accurately examine the subject’s skin characteristics during the study. Nearly half of participants were already taking treatments for their psoriasis at baseline with mean durations of 12 months prior to the study for injectable biologics (15%) and 8.7 months prior to the study for corticosteroids (30%).
Assessments were performed at baseline and weeks 4, 8, and 12 to consult patients and rate their tolerability and the efficacy of the OTC regimen. Draelos took photos of the target sites at baseline and during week 12 to keep track of results, along with each subject’s adherence diary.
“Individuals in the study applied the product to all the areas of plaque involvement, and they were assessed in terms of tolerability and efficacy—both on the subject side as well as on the investigator side. The investigator global assessment [IGA][score] was calculated, as well as looking at the 3 characteristics of the PASI [Psoriasis Area and Severity Index] score, which were induration, scaling, and erythema,” Draelos explained.
Study Results
The research showed statistically significant efficacy and favorable tolerability of the regimen as both a monotherapy and an adjunctive therapy with a prescription psoriasis treatment.
“What we found was a 48% decrease in IGA over the 12 weeks of the study. There were also reductions noted: 48% reduction in erythema, 46% reduction in desquamation, and a 51% reduction in duration,” she shared. “The OTC product was able to work quite successfully in conjunction with no treatment, prescription treatment, or biologics to improve the appearance of psoriasis. I think the benefit of products like this is that they can induce exfoliation. And then there was some anti-inflammatory benefit provided by the turmeric.”
There were no adverse events related to the once-daily OTC gel, and investigators did not observe irritation or edema. Some subjects reported mild irritation, and investigators said this was possibly due to the salicylic acid in the treatment formulation.
“Limitations of the study include its open-label design,” the study noted. “No placebo comparison group was used, and the number of subjects was low for conducting meaningful statistical analysis of 2 study populations (half of the study population [was] being treated at baseline and the other half [was] naïve to treatment). A larger-scale vehicle-controlled study is necessary to corroborate the current findings.”
Understanding Ingredients
Understanding ingredient formulations in OTC products is imperative to explaining their purpose and potential outcomes to patients. In the study Draelos conducted, she explained the purpose of the gel’s main ingredients, especially the one she found interesting—turmeric, which is rich in anti-inflammatories and antioxidants.
She told Dermatology Times, “It’s interesting that turmeric inhibits interleukin 17 and interleukin 21, which are two of the interleukins that are active in psoriasis. They are the targets of some of the monoclonal antibodies that constitute biologics.” The research she published also noted that the molecule progranulin has been implicated in the etiology of psoriasis.
Draelos explained the science behind other ingredients in her published research. “Salicylic acid is a keratolytic, which promotes stratum corneum desquamation. This agent is thought to work by digesting the skin keratin and opening up water-binding sites, which allows the skin scale to desquamate properly,” she said in the study.
She added, “Shea butter, also known as Butyrospermumparkii, is a remarkably stable moisturizing ingredient due to its 7% to 10% unsaponifiable lipid content making it high in bioactive triterpene esters, such as lupeol, [α-amyrin and β-amyrin], and butyrospermol.... Its main fatty acids are oleic and stearic. The triterpene lupeol inhibits lipopolysaccharide-induced iNOS [inducible nitric oxide synthase], COX-2 [cyclooxygenase 2], TNF [tumor necrosis factor]–α, [and] IL-1β and IL-12 mRNA expression. It may be through these anti-inflammatory effects that shea butter assists in psoriasis healing.”
OTC Outlook
Draelos is optimistic with OTC solutions like this psoriasis regimenemerging for patients. “The OTC monograph system, which is in flux now at the FDA, was really developed to provide safe and effective treatments that could be sold at a reduced price direct to consumers,” she said.
In this product’s case, Draelos shared that it would be a possible solution for patients with minor cases of psoriasis, those doing well and wanting to discontinue prescription therapy, those in need of an efficacy boost alongside their prescription, or those needing extra relief between injectables.
Reference
Draelos ZD. The efficacy and tolerability of turmeric and salicylic acid in psoriasis treatment. Psoriasis (Auckl). 2022;12:63-71. doi:10.2147/PTT.S360448
