Proposed hypothesis
With the increasing need to focus on non-surgical interventions for treating vitiligo in patients of diverse age groups, we hypothesize that the narrow-band UVB phototherapy is a highly effective tool for managing the condition because it is safe and produces an appropriate cosmetic appearance and good stability of repigmentation in patients of all ages.
Null Hypothesis
The effective treatment of vitiligo remains elusive because the safety, effectiveness, and efficacy of the narrow-band UVB phototherapy are not well established, which implies that it is yet to be confirmed as a safe method for use in practice.
Proposed methodology
Study design
A quantitative, open clinical trial will be used for a period extending from January 2015 to May 2015. Fifty-two patients with vitiligo aged between 3 to 65 will be included in the study. The aim is to ensure that the clinical trial is tested with patients of all age groups (Sharma, Pai, Pai, Kuruvila & Kolar, 2011). The study targets a patient population with a mean of 25 years and a standard deviation of 8 years. The duration of the condition is expected to range from one to 20 years. In addition, the study will work with patients who will not have taken any other treatment for at least 6 months before the clinical trial begins.
Inclusive/exclusive criteria
Patients with a history of skin diseases such as dysplastic naevus syndrome or skin cancer and those using photosynthesizing medicine as well as people with psychiatric and epileptic disorders will be excluded from the study. The participants are expected to have vitiligo patches ranging from 3 cm to 40 cm.
Procedure
All the patients will be treated with the narrowband UVB machine two times a week. Patients will be requested to take a good bath in their houses or at the research area and a thin film of Vaseline or another appropriate emollient will be applied on the body surface before taking a dose of radiation. The purpose of applying the film is to reduce the corneal layer of the patient’s skin and increase the rate of penetration of the UVB (Katz, Elmore, Wild & Lucan, 2013).
After the patient enters the machine room, the male genitals and female breast nipples will be shielded with a cloth and sunscreen (Katz, et al., 2013).
The researcher will start with irradiation of 200mJ/cm2 for 35 seconds before increasing gradually in each visit. It is expected that in each visit, an increase of 50Mj/cm2 and 8 seconds will be done on each participant.
Proposed Data collection
The response will be assessed once a fortnight for six months. The clinician will outline the lesion on a paper starting with the first visit. A graphic paper will be used to calculate the surface area (SA) of the lesion. The clinician will also record the level of reduction of the lesion after every two weeks and record it along the outline of the lesion on the paper. The clinician will also determine the percentage reduction in the SA of the lesion. After the last session of applying the treatment, the patients will be followed up for four more months.
Proposed Scale of measurement
The clinicians will be expected to note any side effects reported or observed during all the visits.
Figure 1: The proposed scale of measurement
Proposed data analysis
Statistical data analysis will be carried out after the last month of the final follow-up. SPSS tool will be used in the procedure. All the data will be arranged and tabulated according to the recorded numbers and the calculated percentages, averages, and standard deviations. Both paired and unpaired t-tests, ANOVA, and chi-square will be done using the SPSS too. The analysis of variance will be based on a P-value of 0.05 as the level of significance.
References
Katz, D. L., Elmore, J. G., Wild, D. M. G., & Lucan, S. C. (2013). Jekel’s epidemiology, biostatistics, preventive medicine and public health (4th eds.). New York: Elsevier.
Sharma, P., Pai, H. S., Pai, G. S., Kuruvila, M., & Kolar, R. (2011). Response to Narrow-band UVB – Vitiligo-melasma versus Vitiligo: A Comparative Study. American Journal of Clinical Dermatology, 12(2), 127-132.