Accepted Article
Accepted date: 05/05/2014 Title Page
Original article:
Clinical
efficacy of psoralen+sunlight
versus
combination
of Isotretinoin
and
psoralen+sunlight for the treatment of chronic plaque-type psoriasis vulgaris : A randomized hospital based study1 Authors:
Dr Pratik Gahalaut Dr Puneet Singh Soodan Dr Nitin Mishra Dr Madhur Kant Rastogi Dr Hardev Singh Soodan Dr Sandhya Chauhan
Institutional address: Sri Ram Murti Smarak Institute of Medical Sciences, Nainital Road, Bareilly (India) 243001.
Corresponding author: Dr Pratik Gahalaut 69, Silver Estate, Bareilly 243006 (India) Email: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/phpp.12125 This article is protected by copyright. All rights reserved.
Accepted Article Word count:
Text: 3346 (Excluding the references and tables) Abstract: 196. Number of tables: 3 Number of figures: 1
Conflict of interest: PG and NM have received honoraria as speakers fees from Ranbaxy India, Intas pharmaceuticals, Talent India, Microlabs India. Rest of authors report no conflict of interest.
Authors contribution: PG and NM conceptualised the study and edited manuscript. PSS collected data and prepared the initial draft. MKR and HSS reviewed the manuscript critically. SC revised and edited the manuscript for language correction. All the authors approved the final manuscript. PG was the principal investigator and shall act as the guarantor and corresponding auhor.
This article is protected by copyright. All rights reserved.
Accepted Article
Clinical efficacy of psoralen+sunlight versus combination of Isotretinoin and psoralen+sunlight in the treatment of chronic plaque-type psoriasis vulgaris : A randomized hospital based study
Abstract
Background: Isotretinoin has been used in combination with PUVA and NBUVB for treating psoriasis, especially in women of child bearing age. Efficacy of PUVAsol is comparable to PUVA. This study was planned to compare the efficacy of oral PUVAsol with combination of oral isotretinoin and PUVAsol in patients having chronic plaque psoriasis. Methods:
40 patients with psoriasis vulgaris were randomized in two groups. Group A (Control group) received
oral
PUVAsol
only.
Group
B
(intervention
group)
received
oral
PUVAsol+Isotretinoin (0.5 mg/kg/day). Psoriasis Area Severity Index (PASI) was recorded at baseline and weeks 4,8 and 12. DLQI was assessed at baseline and 12 weeks interval. Endpoint of study was PASI 75 or 12 weeks whichever was earlier. Results:
35 patients completed the study. There was a statistically significant difference between the 2 study groups for the number of patients achieving endpoint of PASI 75; PASI scores in each study group at the end of 12 weeks; mean duration to achieve PASI 75; number of sittings of PUVAsol to achieve PASI75; and mean cumulative dosage of 8-MOP consumed by a patient to achieve PASI 75. Conclusion:
Combination of isotretinoin with PUVAsol(RePUVAsol) is more effective compared to PUVAsol alone for treating chronic plaque psoriasis. Key words: photochemotherapy, RePUVAsol, PUVAsol, psoralen, psoriasis
This article is protected by copyright. All rights reserved.
Accepted Article
Clinical efficacy of psoralen+sunlight versus combination of Isotretinoin and psoralen+sunlight in the treatment of chronic plaque-type psoriasis vulgaris : A randomized hospital based study Introduction: Psoriasis is a common, chronic, inflammatory and proliferative condition of the skin. Prevalence rate of psoriasis in India is 0.44 to 2.8%.(1,2) For treating psoriasis rotational, sequential and/or combination therapies are safer and more effective compared to singleagent therapy.(3) Oral retinoids may be used either as monotherapy or in combination with phototherapy (NBUVB)/photochemotherapy (PUVA). The later combination, termed RePUVA is the combined use of retinoids along with drug psoralen and ultraviolet A therapy.(3) Among RePUVA, combinations of PUVA-isotretinoin and PUVA-etretinate are equally effective for severe and widespread psoriasis.(4) However, etretinate and/or acitretin are the commonly mentioned retinoids in literature for RePUVA.(5,6,7) Noteworthy, long half lives and potent teratogenic potential of acitretin and etretinate restrict their use in general population and specifically, in women of child-bearing age.(4) Hence, isotretinoin with a much shorter half life than acitretin has been advocated in combination with PUVA or NBUVB as an alternative for the treatment of psoriasis, especially in females of child-bearing age group.(4,8,9) In a tropical country like India, sun is an inexpensive and inexhaustible source of UVA almost throughout the year. In India PUVAsol is the most commonly used mode of phototherapy for treating psoriasis in India because artificial chambers for PUVA therapy are not readily available.(10) PUVAsol is the intake of psoralen followed by sun exposure as a source of UVA.(10,11) PUVAsol has a favorable cost effectiveness ratio and it’s clinical efficacy is comparable to PUVA.(11) Though a wealth of data is available regarding efficacy of acitretin+PUVA (rePUVA) in psoriasis, data for PUVAsol This article is protected by copyright. All rights reserved.
Accepted Article
and/or isotretinoin in psoriatic patients is meagre.(4,9,12) Hence this study was designed to compare the efficacy of isotretinoin in combination with PUVAsol for chronic plaque psoriasis.
Objective:
Primary objective of this study was to compare the clinical efficacy of oral PUVAsol with combination of oral isotretinoin and PUVAsol in patients having chronic plaque psoriasis. Secondary outcome measure was evaluation of quality of life (QoL) in these patients.
Materials and methods: This randomized open clinical trial was registered in Clinical Trial Registry-India (CTRI/2012/10/003046) and conducted in the department of dermatology of a tertiary level teaching hospital attached to Shri Ram Murti Smarak Institute of Medical Sciences, Bareilly (India) from October 2011 to March 2013. All the patients presenting in psoriasis clinic of the department of dermatology were screened and enrolled in the study based on the below mentioned inclusion and exclusion criteria. Inclusion criteria were patients of chronic plaque psoriasis; aged ≥18 years; having >10% body surface area involvement; literate; diagnosed with psoriasis for ≥3 months; willing for treatment, inclusion in study and regular follow-up. Patients with hepatic or renal impairments, photodermatoses, past or present history of any malignancy or immunobullous disorder, any chronic systemic disorder, pustular or erythrodermic psoriasis, patients having psoriatic arthropathy, concurrent administration of any phototoxic drugs, patients who took treatment irregularly and female This article is protected by copyright. All rights reserved.
Accepted Article
patients who were pregnant or lactating or did not have safe contraception or wanted to become pregnant in 50% improvement in 63% of psoriatic patients respectively with PUVAsol.(18,19) Recently, Chauhan et al showed marked improvement (i.e > 75% reduction in baseline PASI) with PUVA at the end of 12 weeks of treatment.(20) Aggarwal et al reported that endpoint reduction in PASI for PUVA and PUVAsol was comparable at 8 and 12 weeks interval.(11) 12/19 (63.15%) and 16/19 (84.21%) patients in group B achieved PASI 75 and PASI 50 respectively. Various past studies have shown clinical efficacy of oral retinoids and PUVA (RePUVA).(21,22,23) In past patients of severe psoriasis have responded favourably to a combination of isotretinoin and PUVA.(4,12) A similar result has been achieved in the present study by combining isotretinoin with PUVAsol. In the present study, though a decreasing trend in PASI scores was observed in both group A and B at 4 and 8 weeks interval, difference in PASI scores of the two study groups was statistically significant only at the end of 12 weeks. In the present study mean percent reduction in PASI was consistently more for Group B compared to Group A at 4, 8 and 12 weeks. This is in concurrence with the results of past comparative studies which observed that RePUVA is more effective than PUVA alone in clearing plaque-type psoriasis.(5)
This article is protected by copyright. All rights reserved.
Accepted Article
The results of the present study are comparable to past Indian studies which showed 50 to 90% improvement in psoriasis after 8-12 weeks of treatment with PUVAsol are comparable to the present study.(18,19,24) In our study, patients in group B achieved PASI 75 in a mean of 8 weeks and this was significantly less than group A, which achieved PASI 75 in a mean of 10 weeks. Anstey et al reported 30-40% reduction in the number of exposures and the cumulative doses of UVA, when combined with isotretinoin, compared to previous treatment courses in the same patients when retinoid was not co-administered with PUVA.(12) Earlier studies which have compared RePUVA with PUVA found that the doses of both retinoid and PUVA in combination therapy were lower than doses required with the use of these modalities as a single agent.(5,25) To the best of our knowledge, there is only one study in literature comparing Isotretinoin-PUVA with Etretinate-PUVA and/or PUVA combination. In that study, Honigsmann et al showed that duration of treatment (in days) for psoriatic patients treated with combination of Isotretinoin and PUVA was less (24 ± 10 days) compared to patients treated with PUVA alone (29 ± 18 days).(4) Further, they also reported that isotretinoinPUVA and etretinate-PUVA groups had comparable efficacy. Hence, they concluded that isotretinoin can replace etretinate in women of child-bearing age.(4) Recently, Mortazavi et al concluded that combination of isotretinoin-NBUVB can reduce the cumulative NBUVB dose required to treat chronic plaque psoriasis and hence isotretinoin may be a viable option.(8)
In the present study, patients of group A equired a mean of 30 sittings of PUVAsol to achieve PASI 75. This is comparable to a study by Aggarwal et al where patients required
This article is protected by copyright. All rights reserved.
Accepted Article
mean 27.5 sittings of PUVAsol to achieve PASI 75.(11) Earlier Marquis et al reported remissions after 7-49 sessions of PUVAsol.(24) The number of sittings for PUVAsol reduced significantly for patients in group B in the present study. Hönigsmann et al have shown that Isotretinoin accelerates the therapeutic response of PUVA and hence, decreases the number of exposures of PUVA when given in combination with PUVA.(4) They achieved remission with combination of Isotretinoin and PUVA in mean 13 exposures compared to 21 in our study. The difference in number of exposures from our present study may be due to different skin type of study subjects and the fact that we used PUVAsol in combination with Isotretinoin while Honigsmann et al used a combination of PUVA and Isotretinoin. Combining ≥2 modalities often allows treating physician to clear psoriasis faster, thereby exposing patients to fewer doses of each therapy.(3)
Isotretinoin results in reduction of thickness of stratum corneum.(26) Further, isotretinoin flattens plaques, reduces desquamation and may augment the efficacy of PUVA.(12) Isotretinoin may exert a pharmacological effect by inhibiting the release of inflammatory mediators and thus preventing the accumulation of neutrophils in the psoriatic epidermis.(27) Retinoids inhibit IL-6 driven induction of Th 17 cells and keratinocyte production of vascular endotheliai growth factor.(28,29) UVA-sparing potential of RePUVA is well known and this results in a reduced risk of long-term adverse effects of PUVA exposure, mainly for malignancies.(29) Retinoids themselves have anti-carcinogenic potential. (30) Essentially, UV irradiation causes a functional vitamin A deficiency in skin, which begins at UV doses that do not cause detectable sunburn.(31) Isotretinoin is effective in preventing head and neck cancers and it is under trial for various different cancers. Isotretinoin is
This article is protected by copyright. All rights reserved.
Accepted Article
effective in preventing skin malignancies such as basal cell carcinoma or squamous cell carcinoma. Psoriasis and skin cancers have responded to the immunomodulatory, antiinflammatory and anti-tumor activities of isotretinoin.(32) Side effects in two groups: In group A, side effects were encountered in 75% of patients compared to 73.68% of patients in group B. Cheilitis was the most common side effect observed in group B (Isotretinoin + PUVAsol). However, none of the patient discontinued treatment because of the above mentioned side effects observed in the present study. White petrolatum jelly was advised to all the patients of group B to reduce the discomfort due to cheilitis. Noteworthy, none of the study patients in Group B reported deranged lipid profile during or after treatment. This may be due to a relatively lower dosage of isotretinoin (0.5mg/kg) used in the present study. In a RCT, which determined efficacy of isotretinoin plus NBUVB in psoriasis, Mortazavi et al reported mild to moderate erythema, pruritus and nausea as the side effects.(8) None of their patients stopped the treatment due to any side-effects.
Quality of life in study groups: Finlay et al proposed a banding system to felicitate the clinical interpretation of DLQI scores.(17,33) The baseline DLQI scores in both the study groups indicate that the patients who presented for treatment in the present study had ‘very large effect’ on overall Health Related Quality of Life (HRQoL).(17) Many clinical trials have demonstrated the ability of DLQI to detect changes in patient’ QoL before and after treatment.(17)
This article is protected by copyright. All rights reserved.
Accepted Article
In the present study, there was clinically meaningful improvement in DLQI scores for both study groups in the present study. Both the groups, in our study had an absolute DLQI score improvement of ≥ 5, which has been proposed as a potentially useful minimum efficiency
goal for psoriasis. Noteworthy, while 12 weeks of regular treatment with PUVAsol resulted in a shift of band from ‘very large effect’ to ‘moderate effect’, combining isotretinoin with PUVAsol resulted in an even better improvement and shift in band from ‘very large effect’ to ‘small effect’ on patient’s quality of life. Infact DLQI scores decreased to level of
Accepted date: 05/05/2014 Title Page
Original article:
Clinical
efficacy of psoralen+sunlight
versus
combination
of Isotretinoin
and
psoralen+sunlight for the treatment of chronic plaque-type psoriasis vulgaris : A randomized hospital based study1 Authors:
Dr Pratik Gahalaut Dr Puneet Singh Soodan Dr Nitin Mishra Dr Madhur Kant Rastogi Dr Hardev Singh Soodan Dr Sandhya Chauhan
Institutional address: Sri Ram Murti Smarak Institute of Medical Sciences, Nainital Road, Bareilly (India) 243001.
Corresponding author: Dr Pratik Gahalaut 69, Silver Estate, Bareilly 243006 (India) Email: [email protected]
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/phpp.12125 This article is protected by copyright. All rights reserved.
Accepted Article Word count:
Text: 3346 (Excluding the references and tables) Abstract: 196. Number of tables: 3 Number of figures: 1
Conflict of interest: PG and NM have received honoraria as speakers fees from Ranbaxy India, Intas pharmaceuticals, Talent India, Microlabs India. Rest of authors report no conflict of interest.
Authors contribution: PG and NM conceptualised the study and edited manuscript. PSS collected data and prepared the initial draft. MKR and HSS reviewed the manuscript critically. SC revised and edited the manuscript for language correction. All the authors approved the final manuscript. PG was the principal investigator and shall act as the guarantor and corresponding auhor.
This article is protected by copyright. All rights reserved.
Accepted Article
Clinical efficacy of psoralen+sunlight versus combination of Isotretinoin and psoralen+sunlight in the treatment of chronic plaque-type psoriasis vulgaris : A randomized hospital based study
Abstract
Background: Isotretinoin has been used in combination with PUVA and NBUVB for treating psoriasis, especially in women of child bearing age. Efficacy of PUVAsol is comparable to PUVA. This study was planned to compare the efficacy of oral PUVAsol with combination of oral isotretinoin and PUVAsol in patients having chronic plaque psoriasis. Methods:
40 patients with psoriasis vulgaris were randomized in two groups. Group A (Control group) received
oral
PUVAsol
only.
Group
B
(intervention
group)
received
oral
PUVAsol+Isotretinoin (0.5 mg/kg/day). Psoriasis Area Severity Index (PASI) was recorded at baseline and weeks 4,8 and 12. DLQI was assessed at baseline and 12 weeks interval. Endpoint of study was PASI 75 or 12 weeks whichever was earlier. Results:
35 patients completed the study. There was a statistically significant difference between the 2 study groups for the number of patients achieving endpoint of PASI 75; PASI scores in each study group at the end of 12 weeks; mean duration to achieve PASI 75; number of sittings of PUVAsol to achieve PASI75; and mean cumulative dosage of 8-MOP consumed by a patient to achieve PASI 75. Conclusion:
Combination of isotretinoin with PUVAsol(RePUVAsol) is more effective compared to PUVAsol alone for treating chronic plaque psoriasis. Key words: photochemotherapy, RePUVAsol, PUVAsol, psoralen, psoriasis
This article is protected by copyright. All rights reserved.
Accepted Article
Clinical efficacy of psoralen+sunlight versus combination of Isotretinoin and psoralen+sunlight in the treatment of chronic plaque-type psoriasis vulgaris : A randomized hospital based study Introduction: Psoriasis is a common, chronic, inflammatory and proliferative condition of the skin. Prevalence rate of psoriasis in India is 0.44 to 2.8%.(1,2) For treating psoriasis rotational, sequential and/or combination therapies are safer and more effective compared to singleagent therapy.(3) Oral retinoids may be used either as monotherapy or in combination with phototherapy (NBUVB)/photochemotherapy (PUVA). The later combination, termed RePUVA is the combined use of retinoids along with drug psoralen and ultraviolet A therapy.(3) Among RePUVA, combinations of PUVA-isotretinoin and PUVA-etretinate are equally effective for severe and widespread psoriasis.(4) However, etretinate and/or acitretin are the commonly mentioned retinoids in literature for RePUVA.(5,6,7) Noteworthy, long half lives and potent teratogenic potential of acitretin and etretinate restrict their use in general population and specifically, in women of child-bearing age.(4) Hence, isotretinoin with a much shorter half life than acitretin has been advocated in combination with PUVA or NBUVB as an alternative for the treatment of psoriasis, especially in females of child-bearing age group.(4,8,9) In a tropical country like India, sun is an inexpensive and inexhaustible source of UVA almost throughout the year. In India PUVAsol is the most commonly used mode of phototherapy for treating psoriasis in India because artificial chambers for PUVA therapy are not readily available.(10) PUVAsol is the intake of psoralen followed by sun exposure as a source of UVA.(10,11) PUVAsol has a favorable cost effectiveness ratio and it’s clinical efficacy is comparable to PUVA.(11) Though a wealth of data is available regarding efficacy of acitretin+PUVA (rePUVA) in psoriasis, data for PUVAsol This article is protected by copyright. All rights reserved.
Accepted Article
and/or isotretinoin in psoriatic patients is meagre.(4,9,12) Hence this study was designed to compare the efficacy of isotretinoin in combination with PUVAsol for chronic plaque psoriasis.
Objective:
Primary objective of this study was to compare the clinical efficacy of oral PUVAsol with combination of oral isotretinoin and PUVAsol in patients having chronic plaque psoriasis. Secondary outcome measure was evaluation of quality of life (QoL) in these patients.
Materials and methods: This randomized open clinical trial was registered in Clinical Trial Registry-India (CTRI/2012/10/003046) and conducted in the department of dermatology of a tertiary level teaching hospital attached to Shri Ram Murti Smarak Institute of Medical Sciences, Bareilly (India) from October 2011 to March 2013. All the patients presenting in psoriasis clinic of the department of dermatology were screened and enrolled in the study based on the below mentioned inclusion and exclusion criteria. Inclusion criteria were patients of chronic plaque psoriasis; aged ≥18 years; having >10% body surface area involvement; literate; diagnosed with psoriasis for ≥3 months; willing for treatment, inclusion in study and regular follow-up. Patients with hepatic or renal impairments, photodermatoses, past or present history of any malignancy or immunobullous disorder, any chronic systemic disorder, pustular or erythrodermic psoriasis, patients having psoriatic arthropathy, concurrent administration of any phototoxic drugs, patients who took treatment irregularly and female This article is protected by copyright. All rights reserved.
Accepted Article
patients who were pregnant or lactating or did not have safe contraception or wanted to become pregnant in 50% improvement in 63% of psoriatic patients respectively with PUVAsol.(18,19) Recently, Chauhan et al showed marked improvement (i.e > 75% reduction in baseline PASI) with PUVA at the end of 12 weeks of treatment.(20) Aggarwal et al reported that endpoint reduction in PASI for PUVA and PUVAsol was comparable at 8 and 12 weeks interval.(11) 12/19 (63.15%) and 16/19 (84.21%) patients in group B achieved PASI 75 and PASI 50 respectively. Various past studies have shown clinical efficacy of oral retinoids and PUVA (RePUVA).(21,22,23) In past patients of severe psoriasis have responded favourably to a combination of isotretinoin and PUVA.(4,12) A similar result has been achieved in the present study by combining isotretinoin with PUVAsol. In the present study, though a decreasing trend in PASI scores was observed in both group A and B at 4 and 8 weeks interval, difference in PASI scores of the two study groups was statistically significant only at the end of 12 weeks. In the present study mean percent reduction in PASI was consistently more for Group B compared to Group A at 4, 8 and 12 weeks. This is in concurrence with the results of past comparative studies which observed that RePUVA is more effective than PUVA alone in clearing plaque-type psoriasis.(5)
This article is protected by copyright. All rights reserved.
Accepted Article
The results of the present study are comparable to past Indian studies which showed 50 to 90% improvement in psoriasis after 8-12 weeks of treatment with PUVAsol are comparable to the present study.(18,19,24) In our study, patients in group B achieved PASI 75 in a mean of 8 weeks and this was significantly less than group A, which achieved PASI 75 in a mean of 10 weeks. Anstey et al reported 30-40% reduction in the number of exposures and the cumulative doses of UVA, when combined with isotretinoin, compared to previous treatment courses in the same patients when retinoid was not co-administered with PUVA.(12) Earlier studies which have compared RePUVA with PUVA found that the doses of both retinoid and PUVA in combination therapy were lower than doses required with the use of these modalities as a single agent.(5,25) To the best of our knowledge, there is only one study in literature comparing Isotretinoin-PUVA with Etretinate-PUVA and/or PUVA combination. In that study, Honigsmann et al showed that duration of treatment (in days) for psoriatic patients treated with combination of Isotretinoin and PUVA was less (24 ± 10 days) compared to patients treated with PUVA alone (29 ± 18 days).(4) Further, they also reported that isotretinoinPUVA and etretinate-PUVA groups had comparable efficacy. Hence, they concluded that isotretinoin can replace etretinate in women of child-bearing age.(4) Recently, Mortazavi et al concluded that combination of isotretinoin-NBUVB can reduce the cumulative NBUVB dose required to treat chronic plaque psoriasis and hence isotretinoin may be a viable option.(8)
In the present study, patients of group A equired a mean of 30 sittings of PUVAsol to achieve PASI 75. This is comparable to a study by Aggarwal et al where patients required
This article is protected by copyright. All rights reserved.
Accepted Article
mean 27.5 sittings of PUVAsol to achieve PASI 75.(11) Earlier Marquis et al reported remissions after 7-49 sessions of PUVAsol.(24) The number of sittings for PUVAsol reduced significantly for patients in group B in the present study. Hönigsmann et al have shown that Isotretinoin accelerates the therapeutic response of PUVA and hence, decreases the number of exposures of PUVA when given in combination with PUVA.(4) They achieved remission with combination of Isotretinoin and PUVA in mean 13 exposures compared to 21 in our study. The difference in number of exposures from our present study may be due to different skin type of study subjects and the fact that we used PUVAsol in combination with Isotretinoin while Honigsmann et al used a combination of PUVA and Isotretinoin. Combining ≥2 modalities often allows treating physician to clear psoriasis faster, thereby exposing patients to fewer doses of each therapy.(3)
Isotretinoin results in reduction of thickness of stratum corneum.(26) Further, isotretinoin flattens plaques, reduces desquamation and may augment the efficacy of PUVA.(12) Isotretinoin may exert a pharmacological effect by inhibiting the release of inflammatory mediators and thus preventing the accumulation of neutrophils in the psoriatic epidermis.(27) Retinoids inhibit IL-6 driven induction of Th 17 cells and keratinocyte production of vascular endotheliai growth factor.(28,29) UVA-sparing potential of RePUVA is well known and this results in a reduced risk of long-term adverse effects of PUVA exposure, mainly for malignancies.(29) Retinoids themselves have anti-carcinogenic potential. (30) Essentially, UV irradiation causes a functional vitamin A deficiency in skin, which begins at UV doses that do not cause detectable sunburn.(31) Isotretinoin is effective in preventing head and neck cancers and it is under trial for various different cancers. Isotretinoin is
This article is protected by copyright. All rights reserved.
Accepted Article
effective in preventing skin malignancies such as basal cell carcinoma or squamous cell carcinoma. Psoriasis and skin cancers have responded to the immunomodulatory, antiinflammatory and anti-tumor activities of isotretinoin.(32) Side effects in two groups: In group A, side effects were encountered in 75% of patients compared to 73.68% of patients in group B. Cheilitis was the most common side effect observed in group B (Isotretinoin + PUVAsol). However, none of the patient discontinued treatment because of the above mentioned side effects observed in the present study. White petrolatum jelly was advised to all the patients of group B to reduce the discomfort due to cheilitis. Noteworthy, none of the study patients in Group B reported deranged lipid profile during or after treatment. This may be due to a relatively lower dosage of isotretinoin (0.5mg/kg) used in the present study. In a RCT, which determined efficacy of isotretinoin plus NBUVB in psoriasis, Mortazavi et al reported mild to moderate erythema, pruritus and nausea as the side effects.(8) None of their patients stopped the treatment due to any side-effects.
Quality of life in study groups: Finlay et al proposed a banding system to felicitate the clinical interpretation of DLQI scores.(17,33) The baseline DLQI scores in both the study groups indicate that the patients who presented for treatment in the present study had ‘very large effect’ on overall Health Related Quality of Life (HRQoL).(17) Many clinical trials have demonstrated the ability of DLQI to detect changes in patient’ QoL before and after treatment.(17)
This article is protected by copyright. All rights reserved.
Accepted Article
In the present study, there was clinically meaningful improvement in DLQI scores for both study groups in the present study. Both the groups, in our study had an absolute DLQI score improvement of ≥ 5, which has been proposed as a potentially useful minimum efficiency
goal for psoriasis. Noteworthy, while 12 weeks of regular treatment with PUVAsol resulted in a shift of band from ‘very large effect’ to ‘moderate effect’, combining isotretinoin with PUVAsol resulted in an even better improvement and shift in band from ‘very large effect’ to ‘small effect’ on patient’s quality of life. Infact DLQI scores decreased to level of
