Related Experiment Video
Updated: Aug 6, 2026
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Safety and tolerability in the MORE trial
1Department of Dermatology, Baylor College of Medicine, Houston, Texas, USA.
Cutis
|August 17, 2006
Summary
Adapalene gel 0.1% demonstrated good tolerability and safety in a large real-world acne study. High patient adherence suggests it can improve treatment outcomes for moderate to severe acne.
Area of Science:
- Dermatology
- Pharmacology
Background:
- Patient adherence is crucial for effective acne treatment.
- Cutaneous irritation and adverse events can negatively impact adherence.
Purpose of the Study:
- To evaluate the safety and tolerability of adapalene gel 0.1% in a real-world setting.
- To assess the impact of adapalene gel 0.1% on patient adherence to acne treatment.
Main Methods:
- The Measuring Acne Outcomes in a Real-World Experience (MORE) trial included 1396 subjects on initial combination therapy and 468 on add-on therapy.
- Adverse events, cutaneous tolerability, and adherence were evaluated.
Main Results:
- Adverse events were uncommon (5.8%) and generally mild, with skin disorders being the most frequent (2.7%).
- Investigator-rated cutaneous tolerability was high.
- Adherence to therapy was high in both treatment groups.
Conclusions:
- Adapalene gel 0.1% is safe and well-tolerated in patients with moderate to moderately severe acne.
- The favorable safety and tolerability profile is likely to enhance treatment adherence and improve outcomes.
Related Concept Videos
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
01:11Bioavailability Study Design: Single Versus Multiple Dose Studies
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
01:23Toxicity Testing in Animals
Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
01:13Therapeutic Index
The therapeutic index of a drug is a key parameter in pharmacology that quantifies the relative safety of a drug by calculating the ratio between the dose that causes toxicity in half the population (50%) to the dose that proves to be effective for half the population (50%). It provides a spectrum of doses for a particular drug ranging from effective to potentially toxic. To illustrate, consider an anticoagulant agent like warfarin. It possesses a narrow window within its therapeutic index to...