Choosing the right clinical trial design is crucial for skincare and supplement brands looking to validate the efficacy of their products. The design you choose can significantly impact the credibility of your findings, the cost of the study, and, ultimately, consumer trust in your brand. Please keep in mind that choosing a study design is just one part of planning a successful clinical trial. Choosing your study methodologies is just as important.
This blog explores three popular types of study designs—Single Group Clinical Trials, Randomized Control Trials (including Double-Blind Placebo-Controlled studies and Crossover studies), and Perception Studies—highlighting their pros and cons from the perspective of supplements and skincare brands.
1. Single Group Clinical Trial
In a single-group clinical trial, all participants receive the same treatment, and there is no comparison group or placebo involved. This design is often used for initial exploratory studies or when it's unethical or impractical to withhold treatment from a control group. If you don't have a high budget but still want to conduct a clinical study, a single-group study can be a good, cost-effective option for you as well.
Pros:
Simplicity and Lower Cost: Less complex to manage and typically less expensive than trials involving multiple groups.
Quick Setup: Faster to start, as it requires less planning around randomization and control measures.
Direct Results: Provides direct information about the effects of a product on a specific group without external comparison.
Cons:
Lack of Control Group: Without a control or comparison group, it's difficult to determine whether outcomes are due to the treatment or other factors.
Lower Credibility: This may be considered less scientifically rigorous, which can affect the perceived quality of the evidence.
Limited Generalizability: Results may not be generalizable to broader populations.
Brand Perspective: This design might be suitable for demonstrating the basic efficacy of a new ingredient or formulation where the primary aim is to observe direct effects rather than comparative efficacy. When paired with objective data, such as biomarkers (e.g., bloodwork, microbiome testing), data from trackers (sleep, fitness levels, blood pressure), bodyweight scales, or expert skin and hair grading, this can be a robust study design to show the efficacy of your product.
2. Randomized Control Trial (RCT)
RCTs involve randomly assigning participants to either the treatment group or the control group. This design can be further categorized into Double-Blind Placebo-Controlled studies, where neither the researchers nor the participants know who is receiving the treatment or placebo, and Crossover studies, where participants receive both the treatment and placebo at different times. Crossover studies can also be blinded.
Pros:
High Credibility: Considered the gold standard for clinical trials due to its ability to minimize bias.
Clear Comparative Data: Provides a clear comparison between the treatment and control groups, enhancing the validity of the results.
Versatility: Can be adapted into more complex designs like double-blind or crossover to further enhance data reliability.
Cons:
Higher Cost and Complexity: More resource-intensive in terms of time, management, and finances.
Participant Compliance: Requires strict participant adherence to protocols, which can be challenging to monitor.
Risk of Attrition: Higher complexity and longer duration can lead to greater participant dropout rates.
Brand Perspective: Ideal for brands seeking robust evidence to support claims of superiority over placebo effects or competing products. Particularly useful where strong proof is needed to support marketing claims. To make RCTs more robust, we recommend including biomarkers, trackers (sleep, fitness), bodyweight scales, or expert grading. Hint: The FTC favors RCTs!
3. Perception Study
Perception studies primarily rely on participants' subjective feedback after using a product. These studies assess personal experiences, preferences, or perceived benefits rather than clinical outcomes.
Pros:
Consumer Insight: Offers direct insights into consumer satisfaction and product perception, which can be powerful for marketing.
Lower Cost: Generally less expensive and easier to conduct than clinical efficacy trials.
Faster Results: Can be completed quickly, allowing faster time-to-market for product adjustments based on feedback.
Cons:
Subjective Data: Relies heavily on personal opinion, which can vary widely and may not accurately reflect the product’s effectiveness.
Limited Scientific Rigor: Provides weaker evidence of efficacy, potentially affecting credibility with scientifically minded consumers or regulators.
Potential Bias: Results can be influenced by participant expectations or placebo effects.
Brand Perspective: Useful for gauging initial consumer reactions to a product or for fine-tuning marketing messages. Skincare brands regularly use perception study as the foundation for their product claims. This study design can't include any objective markers from expert grading or biomarkers.
Choosing the right study design for your skincare or supplement brand depends on multiple factors, including the type of product, the claims you wish to substantiate, and your budget. While RCTs offer the highest level of scientific evidence, they are also the most resource-intensive. Single-group trials and perception studies provide valuable data with less complexity but come with limitations in credibility and rigor. Balancing these factors will help determine the most appropriate design for your product's needs and goals.
Not sure which study design to choose for your brand? Talk to our research team today and get a free consultation. Contact us HERE.