Evaluation of using fractional CO2 laser combined with narrow-band ultraviolet B phototherapy vs NB-UVB monotherapy for non-segmental vitiligo

Evaluating the usefulness of fractional CO2 laser combined with narrow band ultraviolet B (UVB) compared to phototherapy with only NB-UVB in the treatment of non-segmental vitiligo.

A clinical trial with a control group, with parallel groups, blinded, randomized, on 15 patients.

Study location: Baran Clinic. For each patient, one side of the body is treated with NB-UVB alone, while the other side is treated with combined treatment . a picture will be taken of each patient from both sides of the body before treatment .After treatment, the patient will be evaluated by the doctor. the photo will be taken again. The doctor will not know which side of a patient received phototherapy alone or combined treatment and only evaluates repigmentation

Inclusion criteria: over 18 years old, Non-segmental vitiligo, Has generalized lesions, 3 months have passed since their last treatment, The lesion has been stable during the last year, Exclusion criteria: pregnancy or breastfeeding, History of serious photosensitivity, Suffering from eye cataracts or skin cancer, History of keloid scars.

All patients will receive phototherapy sessions on both sides of the body 3 times per week for three months . The initial dose of UVB is 240 J/cm2 and each session increases by 20% to achieve the minimum erythema dose. The control group will receive only phototherapy. In the intervention group, simultaneously with phototherapy, three sessions of fractional CO2 laser therapy are performed using a fractional CO2 laser, with energy settings of 10 mJ/cm2 at a penetration depth of 10600 mm, density 25%, frequency 1 time per month and once every time for three months on Vitiligo lesions of left or right side in a randomly manner.

repigmentation score

In this study, two types of treatment are applied to patients. The first treatment includes the combination of phototherapy and laser and the second treatment is phototherapy alone. The first step is to randomize on which side of the patient's body phototherapy and laser will be performed together. First, a number is considered for each patient. From 1 to 15. Then the patients are divided into two groups, even and odd, by throwing a dice. In the next step, they are placed on the basis that, for example, those whose number is even will receive phototherapy treatment on the right side of the body. In this way, the combined laser and phototherapy treatment is performed on the right side of people with odd numbers.

To eliminate the interfering effect of the doctor's level of experience and literacy, the treatment phase is performed only by the student and the evaluation phase is performed by the dermatologist. Before the treatment, each patient is photographed from both sides of the body with a camera, from a certain distance, and a certain intensity of the camera light, in a certain and fixed place on each side of the body by the student. Therefore, each patient has one photo for the left side and one photo for the right side before the treatment. After a certain period of treatment for all patients, the patient's evaluation will be done by the doctor. But before the doctor's evaluation, the photo will be taken again with the same conditions mentioned by the student. In fact, there will be 2 pieces of photos for each patient from each side of the body. One picture before the treatment and one picture after the treatment. Therefore, the doctor will not know which side of a patient received phototherapy alone or the combined treatment and only evaluate the repigmentation and reports the changes of two photos

Only part of the data, such as information related to the main outcome or similar, can be shared

The access period starts 6 months after the results are published

It will be available only to researchers working in academic and scientific institutions

Researchers working in academic and scientific institutions can check the data, perform the statistical analysis they want to match, compare this study with other similar studies, and share the results if necessary.

Email to:A.kazeminejad@mazums.ac.ir

After communicating by email, data and results will be available if conditions are met