To examine the impact of topical retinoid Adapalene application length, dose frequency, and side effects in Acne vulgaris.
Tagged: Medicine & Healthcare
3.1 Introduction
Acne vulgaris is a chronic skin disorder that primarily affects teens and young adults. This section describes the various methodologies used to assess the duration of application, frequency of dosing, and adverse effects of topical retinoid adapalene in acne vulgaris, including study design, inclusion and exclusion criteria, sample size, study groups, adapalene type, statistical analyses, and so on.
3.1 Study Design
The current investigation was a randomized controlled trial (RCT) using a split face non-blinded design. An RCT is an experimental process designed to decrease certain forms of bias while evaluating the efficacy of novel therapies; this is accomplished by randomly assigning topics to two or more groups and, managing them appropriately, then comparing them with a measurable response. RCT was one of the most potent and fundamental strategies in clinical research. RCTs are employed in clinical research to address patient-related problems and serve as the foundation for regulatory body approval decisions in developing novel drugs.
3.2 Selection criteria of the study
3.2.1 Inclusion criteria
- Age range: 14 to 40 years (From pubertal onset)
- Acne of grades 1 to 2
3.2.2 Exclusion criteria
- Women who are pregnant or lactating/breastfeeding
- Adapalene-related hypersensitivity concerns
- Patients who refuse to give informed permission are unable to understand the procedure and are recalcitrant.
- Patients who have not used any systematic medicine for a month
- Patients had numerous or ongoing cosmetic operations on their faces.
3.3 Sample Size
The study was conducted in line with excellent clinical practice. In this study, 97 patients were enrolled. Assuming a dropout during follow-up, the needed sample size was roughly 130. The other two research protocol groups had the same number of patients.
3.4 Study subgroups
Computer-generated randomization was used to assign individuals to one of three treatment regimens.
Group 1: The face is divided vertically into two parts using the split-face technique; topical adapalene is administered nightly on one half and alternating nights on the other.
Group 2: Topical adapalene application utilizing a vertical split-face approach; one side hourly on a daily basis and the other hourly on alternate days.
Group 3: Split face technique vertical, topical adapalene is used for half an hour on one side daily and after washing it, and half an hour on the other side alternating days.
3.5. Type of adapalene and duration
The participants underwent the screening process, including entrance requirements, medical history, demographics, and baseline evaluations. The baseline efficacy and safety tests for qualified patients were recorded, and the analysis prescription was offered. In this investigation, 0.1% adapalene was employed. Patients were told to apply adapalene 0.1% once a day for 12 weeks. The effectiveness of topical adapalene overnight therapy is assumed to be 70%. Using the same medicine at 40% and sleeping on alternate days, the significance level was 5%. Patients were assessed at weeks 0, 4, 8, and 12. Individual particular lesions are counted, and CEA is measured while on follow-up. Because of Acne grading, the Investigator’s global scale was not assessed throughout the follow-up.
3.6 Measuring acne grade: (Investigator Global Assessment Scale) US FDA Recommendation
The Investigator’s global assessment scale was used to determine acne grade. This scale summarizes the severity of Acne in five categories (reported only in whole numbers) (e.g., 0 to 4). To reduce inter-observer variability, each grade should be characterized by a separate and clinically meaningful morphologic description. Because the IGA scale is meant to be a qualitative assessment of the subject’s state, the severity grade definitions should not include numerical lesion ranges. In this study, we only evaluated acne grades 0, 1, and 2 and omitted other grades.
0 – Clear skin with no irritation
Grade 1: Almost clean skin with a few non-inflammatory lesions and at least one tiny inflammatory lesion.
Grade 2: Mild severity, with some non-inflammatory lesions and just a few inflammatory lesions (papules/pustules).
Grade 3: Moderate severity, with several non-inflammatory lesions and maybe some inflammatory lesions, but only one tiny nodular lesion.
Grade 4: Severe, >Grade 3, many non-inflammatory and inflammatory lesions, and only a few nodular lesions.
3.7 Safety and tolerability measure:
A longitudinal line drawn across the nasal septum can physically divide the face into two portions for inspection. The degree of graded erythema and inflammation and the number of nodules, papules, and pustules on each side of the face were tallied and reported at the start of the test. Following the initial research, the degree of inflammation, erythema, and safety were assessed by increasing the number of lesions by counting the technique for each lesion type. The clinical erythema evaluation scale was used to examine the numerous adverse effects of patients treated with adapalene. This scale explains the erythema in the five severity degrees (only total values are presented) (e.g., 0 to 4).
Grade 0- Clear, with no signs
Grade 1: Almost clear with a hint of crimson
Grade 2: Mild, noticeable redness
3.8 Statistical Analysis
The data was manually input into an excel file before being uploaded to the SPSS 20.0 edition. In each variable, descriptive statistical measurements were taken. The mean, and standard deviation (mean± SD), describe variables. ANOVA is used to determine if statistically significant differences exist between the means of three or more separate (unrelated) groups.
3.9 Summary
The current section describes the numerous methodological techniques employed in the present investigation. It goes into great depth about everything from research design to inclusion and exclusion, as well as the multiple methods used to quantify the severity of Acne and statistical analysis. The current investigation’s findings will be explained in the next chapter.
