A study of comparison of PUVASOL and NBUVB in patients with vitiligo

Vaaruni Ravishankar; Santoshdev P Rathod; Siddhartha Saikia; Raju G Chaudhary; Rekha B Solanki

doi:10.4103/Pigmentinternational.Pigmentinternational_

ORIGINAL ARTICLE

Year : 2018 | Volume : 5 | Issue : 2 | Page : 96-102

A study of comparison of PUVASOL and NBUVB in patients with vitiligo

Vaaruni Ravishankar¹, Santoshdev P Rathod², Siddhartha Saikia², Raju G Chaudhary², Rekha B Solanki²
¹ Department of Dermatology, Chettinad Hospital and Research Institute, Chennai, Tamil Nadu, India
² Department of Dermatology, Smt. NHL Municipal Medical College, VS Hospital, Ahmedabad, Gujarat, India

Date of Web Publication

14-Dec-2018

Correspondence Address:
Dr. Vaaruni Ravishankar
C, 23, Srinidhi, Fourth Main Road, Indira Nagar, Adyar, Chennai 600020, Tamil Nadu
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/Pigmentinternational.Pigmentinternational_

Abstract

Introduction: Vitiligo is an acquired, hypomelanotic disease, characterized by circumscribed depigmented macules. Phototherapy, which is the use of ultraviolet irradiation with or without exogenous photosensitizer is a well established treatment option. Psoralens with sunlight as the source of ultraviolet A-rays is known as PUVASOL. Narrow band Ultraviolet B phototherapy (NBUVB; 311–313 nm) has been introduced over the past decade. Aims: To study the clinical effectiveness and assess the safety of NBUVB and PUVASOL therapy in Vitiligo patients. Methods: The patients were randomly allocated in to two groups containing 25 patients each. Group A patients received NBUVB with an initial dose of 250 mJ/cm2, incremented by 20% with each subsequent visit till optimum dose was achieved, twice a week on non-consecutive days. Group B patients received PUVASOL-oral Trimethylpsoralen or topical 0.2% w/w Trioxsalen followed by exposure to sunlight, twice a week on non-consecutive days. The extent of repigmentation was documented at regular intervals upto 6 months. Results: Amongst patients receiving NBUVB and PUVASOL, 56% and 48% had ≥50% repigmentation respectively. Disease was unstable in 48% and 36% of patients prior to commencement of therapy which reduced to 12% and 16% after therapy, respectively. 16% and 36% of the patients experienced side effects and 76% and 48% showed excellent colour match of the repigmented patches respectively. Conclusion: While both PUVASOL and NBUVB are both good therapeutic options; NBUVB therapy is found to be more effective and more cosmetically acceptable, with better colour matching of lesions and minimal adverse effects.

Keywords: NBUVB, phototherapy, psoralen, PUVASOL, vitiligo

How to cite this article:
Ravishankar V, Rathod SP, Saikia S, Chaudhary RG, Solanki RB. A study of comparison of PUVASOL and NBUVB in patients with vitiligo. Pigment Int 2018;5:96-102

How to cite this URL:
Ravishankar V, Rathod SP, Saikia S, Chaudhary RG, Solanki RB. A study of comparison of PUVASOL and NBUVB in patients with vitiligo. Pigment Int [serial online] 2018 [cited 2023 Mar 30];5:96-102. Available from: https://www.pigmentinternational.com/text.asp?2018/5/2/96/247510

Introduction

Vitiligo is an acquired, idiopathic disease characterized by depigmented macules.^[1] Phototherapy, usingultraviolet (UV) irradiation (with or without an exogenous photosensitizer), is a well-established treatment option.^[2] Psoralens with sunlight as the source of ultraviolet A (UVA) rays are known as PUVASOL. Narrow band ultraviolet B phototherapy (NBUVB) has been introduced over the past decade. In India, bearing in mind, the disease stigma and low socioeconomic status of the population, there is a pressing need for cost effective and easily accessible therapeutic interventions. Numerous studies have demonstrated the clinical efficacy of phototherapy.^{[3],[4],[5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17]} However, in India, this has to be further evaluated. The aim of the study was to evaluate the therapeutic response and assess the safety of NBUVB and PUVASOL in vitiligo patients.

Patients and methods

The study was open, non-randomized, and prospective and was conducted in the outpatient department (OPD) of a tertiary care center over a period of 2 years. The study began after getting permission from the Institutional Ethical Committee. Written and informed consent from the patients to be observed and photographed were obtained. A total of 50 patients of vitiligo were selected on the basis of the following inclusion and exclusion criteria.

Inclusion criteria:
1. Patients with segmental, nonsegmental, generalized and localized vitiligo and patients with history of stable or progressive vitiligo.
2. Patients in the age group 18–60 years.
3. Patients who can regularly follow up in OPD.
Exclusion criteria:
1. Patients <18 years of age and >60 years of age.
2. Patients with a history of photosensitive disorders, skin cancer, renal or hepatic disease, lesions over genitals, pregnancy, and lactation.
3. Patients with a history of spontaneous repigmentation of the depigmented macules.

Procedure: The patients with vitiligo were segregated into two groups containing 25 persons each. The patients with vitiligo in Group A received NBUVB (patients who could visit biweekly) and Group B received PUVASOL (patients who could visit fortnightly).

A detailed history was taken, and clinical examination was conducted on each patient with the recording of generalized percentage of body surface area (BSA) involvement of vitiligo and vitiligo disease activity (VIDA) score.^[4] Baseline liver and renal function tests were performed before the initiation of PUVASOL therapy.

Treatment protocol:

NBUVB: Before starting therapy, the patients with vitiligo were sent to the phototherapy chambers and counseled regarding the safety profile, importance of adherence, compliance and limitations of therapy.
- Equipment used:
1. Whole body, Surya 240 NB unit (V Care UV therapy unit, Bangalore, India) with 24 tubes (TL-01) − 100 W, 6 ft in the peak range of 311 nm − for generalized vitiligo.
2. Multipurpose localized unit (V Care UV therapy unit, Bangalore, India) with 16 NB tubes (TL-01) − 20 W, 2 ft − for localized vitiligo.
  - As such, all those 25 patients were of skin type IV and V, the MED was not calculated and an initial dose of 250 mJ/cm² was started.^[18] The treatment was administered twice a week (due to logistical constraints with respect to travel) on nonconsecutive days. The dose and hence irradiation time were incremented by 20% with each subsequent visit till optimum dose was achieved to obtain minimal erythema in the lesions. If symptomatic erythema, burning, pain or blistering developed, further treatment was withheld until the resolution of symptoms. After resolution of overdose symptoms, the dose administered was 50% of the last dose with subsequent increments by 10%.
PUVASOL: This group of 25 patients were given oral psoralen (trimethylpsoralen in the dose of 0.3–0.6 mg/kg in generalized vitiligo) if BSA ≥20% or told to apply topical psoralens (0.2% w/w trioxsalen in localized vitiligo) if BSA <20% and then expose their lesions to sunlight (after 2 h following oral/1 h following topical). The treatment was given twice a week on nonconsecutive days. These patients were instructed to expose themselves to the sun between 10:30 AM to 11:30 AM or 3:30 PM to 4:30 PM for 5 minutes initially, which was increased stepwise to 15 minutes or till appearance of minimal erythema.

In both groups, during treatment, only affected parts were exposed. Genitalia and other uninvolved parts were protected. Eyes were protected with UV blocking B2 toric glasses during the procedure in the case of NBUVB, and were protected from the time of exposure to psoralen until sunset that day in the case of PUVASOL. All patients were asked to apply emollients and a sunscreen with an sun protection factor (SPF) of at least 30 after treatment and on a daily basis. All patients were reassessed at regular intervals (1 month, 3 months, 6 months, 9 months, 1 year) and lesional photographs were taken at baseline and thereafter. Repigmentation was assessed and graded as <25%, 25% to <50%, 50%–75% and >75%. Patients with <50% and ≥50% repigmentation were considered to have minimal-mild response and moderate-complete respectively.^[9] The type of repigmentation − diffuse, perifollicular, marginal, or combined was also noted.^[19]

Statistical analysis

Parametric T test, chi-squared test and non-parametric Mann–Whitney U test were conducted wherever applicable.

Results

The maximum number 18 (36%) of patients were in the age group of 21–30 years. The mean age of onset was 33.31 years. Out of 50 patients, 22 (44%) were males and 28 (56%) were females. Female-to-male ratio was 1.27:1. Among them, 62% of the patients were having skin type IV and 38% patients were having skin type V, as the study group was selected entirely from Indian population. Of the 50 patients, 10% had >75% repigmentation. Among the patients receiving NBUVB and PUVASOL, 56% and 48% had moderate-complete repigmentation, respectively. Parametric T test (t = 0.49) was not significant.

In the NBUVB and PUVASOL groups, disease was unstable in 48% and 36% of patients prior to commencement of therapy. At the end of the therapy, activity was present in 12% and 16% of patients, respectively. Wilcoxon rank test/Mann–Whitney rank test was conducted and found to not be significant (P = 0.1265). Fifty and 33.3% of the patients with active disease, and 61.6% and 56.3% with stable disease prior to commencement of therapy had moderate-complete repigmentation, respectively. Among the patients having ≤5 years of duration of vitiligo, 87.10% of the patients had repigmentation >25% as opposed to 63.20% of the patients having >5 years of disease duration.

Maximum response was seen in the eight patients of focal vitiligo where moderate-complete repigmentation was seen in 87.5% of the patients. Poor response was seen in segmental and acral vitiligo, where only one of the three patients and four of the ten patients had moderate repigmentation, respectively.

Of the 25 patients receiving NBUVB, 16% patients had <25% repigmentation with a mean of 41.5 sittings and 12% had ≥75% repigmentation with a mean of 83.6 sittings.

Eighty and 44% of the patients receiving NBUVB and 72% and 32% of the patients receiving PUVASOL showed perifollicular and marginal repigmentation, respectively. Seventy-six percentage of the patients receiving NBUVB and 48% of the patients receiving PUVASOL showed excellent color match of the repigmented patches with the surrounding unaffected skin. This was found to be statistically significant (z = 2.8022). Sixteen and 36% of the patients receiving NBUVB and PUVASOL, respectively, experienced side effects in the form of mild erythema and pruritus and 4% of the patients receiving PUVASOL developed bullae. This was found to be statistically significant on carrying out chi-square test (χ² = 21.2) [Table 1],[Table 2],[Table 3],[Table 4],[Table 5].

Table 1: Repigmentation observed on completion of therapy

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Table 2: Stability achieved with phototherapy

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Table 3: Repigmentation achieved versus initial activity of disease

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Table 4: Effect of type of vitiligo on response of treatment

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Table 5: Response to treatment versus mean number of sittings (n = 25)

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Discussion

Vitiligo is an acquired, idiopathic disease, characterized by circumscribed depigmented macules.^[1] Melanocytes absent from lesional skin due to their destruction have been suggested to be the key event in the pathogenesis of vitiligo.^[20] Vitiligo is not a life threatening disease. However, it frequently induces emotional distress and the psychosocial effect should not be underestimated.^[21] Ideally, the aim of the vitiligo treatment is to obtain complete and permanent repigmentation toward the color of the surrounding normal skin.

In the present study, a good therapeutic response was seen to phototherapy. This was in comparison to Kumar and Rao study, in which 66% had ≥25% repigmentation^[9] [Figure 1], [Figure 2], [Figure 3].

Figure 1: Therapeutic response to NBUVB at baseline and 6 months. The decreased response in the hands in comparison to other areas highlights the resistance of acral sites to therapy

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Figure 2: Therapeutic response to NBUVB at baseline and 6 months

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Figure 3: Therapeutic response to PUVASOL at baseline and 6 months in sites which can be well exposed to the sun

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The therapeutic effectiveness in terms of inducing repigmentation was better with NBUVB. However, this was not found to be statistically significant and could be attributed to the smaller study population. In Bhatnagar et al. study, 52% patients receiving NBUVB and 32% patients receiving PUVA had ≥50% repigmentation which was in accordance with the present study. The encouraging response to PUVASOL makes it a promising therapeutic option for patients in remote areas.

Leucotrichia was present in 16% patients, out of which 62.50% patients showed less repigmentation supporting the fact that leucotrichia is a poor prognostic factor in the patients with vitiligo. Koebner’s phenomenon was present in 12.0% of patients, of which 66.67% had progressive disease suggesting the role of Koebner’s phenomenon in progression of the disease.

In the present study, greater repigmentation was noted in patients with shorter duration of disease. This indicates a need for prompt intervention during the initial disease stages. Phototherapy also helped achieve disease stability, with NBUVB being more advantageous. Stability refers to no new lesions and no increase in size of existing lesions for at least 3 months.^[22] This was comparable to Bhatnagar et al. study where, in the NBUVB and PUVA groups, disease was unstable in 40 and 25% patients prior to commencement of therapy and at the end of the therapy, activity was present in 16% and 16% patients, respectively.^[8]

In the present study, repigmentation was much less in patients with active disease before starting phototherapy compared with those who had stable disease. This was in comparison to Bhatnagar et al. study, where 50% patients receiving NBUVB having active disease, and 80% patients receiving PUVA having active disease, developed <50% repigmentation.^[8] Therefore, a thorough history taking regarding occurrence of new lesions is required before deciding the therapeutic modality to be employed.

In both the groups, perifollicular and marginal repigmentation was observed, with perifollicular being more common. This was in comparison to Yones et al. study, where 88% and 64% of the patients receiving NBUVB and 92% and 36% of the patients receiving PUVA showed perifollicular and marginal repigmentation, respectively,^[7] thereby highlighting the importance of the hair follicle melanocyte reservoir in contributing to repigmentation.

In the present study, NBUVB showed better color match between the repigmented patches and the surrounding unaffected skin. Some patients on PUVASOL had repigmentation noticeably darker than the surrounding unaffected skin. In Yones et al. and Parsad et al. study, 100% and 80% of the patients receiving NBUVB and 44% and 35% of the patients receiving PUVA showed color match with the surrounding skin.^[7],[23]

Maximum repigmentation was seen in focal vitiligo and least repigmentation was seen in segmental vitiligo. Therefore, therapeutic goals and patient expectations should be balanced based on the type of presentation. In the present study, it was observed that achieving a faster and better response is directly associated with number of exposures and good adherence to therapy. These results were comparable with Kishan Kumar et al. study, where 34% patients had <25% repigmentation with a mean of 19.48 sittings, 48.67% patients had 25–75% repigmentation with a mean of 51.91 sittings and 17.33% patients had ≥75% repigmentation with a mean of 74.92 sittings.^[9] Hence, counseling the patient about the need for compliance, before initiation of therapy is a must.

The adverse effects were minimal in the form of xerosis, erythema, and pruritus. Two patients receiving PUVASOL developed bullae over vitiligo patches and for that further treatment was withheld till the symptoms subsided. Thus, due to minimal side effects, we can clearly establish the safety profile of NBUVB therapy over PUVASOL therapy [Figure 4].

Figure 4: Side effects due to PUVASOL can be seen as a result of phototoxicity in the form of bullae, erythema, and erosions

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Taking into account the lower socioeconomic status of a majority of the Indian population, PUVASOL is a cost effective and feasible therapeutic option, when there is a lack of affordability for hospital based devices or in far to reach areas where there is lack of transportation facilities. However, NBUVB therapy is found to be more effective and more cosmetically acceptable, with better color matching of lesions and minimal adverse effects. For better conclusion, large population-based studies are required with long-term follow-up.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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