One Key Factor to Avoid Clinical Trial Failure with Topicals
Having the right formulation is critical for topical pharmaceuticals. One of the most important factors is avoiding symptom relief factors in the formulation.
Most skin conditions have physical symptoms that can be addressed to some extent using a cosmetic approach. For example, psoriasis has plaques—unsightly, itchy and inflamed patches of skin. Products that include moisturizing ingredients, like lotion, can relieve some symptoms. They don’t however, address the underlying issues.
When creating a topical pharmaceutical that addresses psoriasis, for example, it’s important to have a formulation that has a good consistency, but does not contain ingredients that compete with the API. This is of critical importance, particularly when you get to clinical trials.
If the formulation has excipients that have active properties, like moisturization, you may face problems with your placebo group when you get to clinical trials. If the placebo group sees perceived symptom relief, your clinical trial will likely fail.
This is one of the key challenges when creating an effective topical formulation. It has to have a good consistency but it can’t have any excipients that have traits that could affect the efficacy of the API. The formulation must also be done so there is no interference, in terms of symptom relief.
Quality by Design, which Tergus pioneered for topical development, is one way to ensure that your formulation is optimized, keeping all of the success factors in mind. This kind of challenge is what we live for at Tergus.
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