A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance

Background: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses. Aims and Objectives: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo. Methods: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases. Results: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline. Limitations: Small sample size and a short follow-up period of our study were major limitations. Conclusion: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone

A morphometric and immunohistochemical study of melanocytes in periorbital hyperpigmentation.

Background: An increase in number of melanocytes in the basal cell layer of the epidermis is an important feature in many disorders of hyperpigmentation. In this study, we attempted an objective evaluation of the linear density of melanocytes and keratinocytes, along with other epidermal characteristics, in periorbital hyperpigmentation using immunohistochemistry and morphometric techniques. Methods: Melanocytes and epidermal parameters were assessed by digital morphometry in 30 newly diagnosed cases of periorbital hyperpigmentation and 14 controls from the post-auricular region. Melanocytes were labelled with the immunohistochemical stains, Melan-A and tyrosinase. We studied the linear keratinocyte density, mean linear melanocyte density, ratio of melanocytes to keratinocytes, the ratio between inner and outer epidermal length, maximum epidermal thickness and minimum epidermal thickness. Results: Melan-A expression of melanocytes showed strong positive correlation (r = 0.883) with the tyrosinase expression. Mean linear melanocyte density was 24/mm (range: 13–30/ mm) in cases and 17/mm (13–21/mm) in controls and this difference was statistically signifi cant (P < 0.001). The mean ratio of melanocyte to keratinocyte was 0.22 (0.12– 0.29) in cases and 0.16 (0.12–0.21) in controls; again, this difference was statistically signifi cant (P < 0.001). There was a mild negative correlation with linear keratinocyte density (r = −0.302) and the ratio between inner and outer epidermal length (r = −0.456). However, there were no differences in epidermal thicknesses. Limitations: There were fewer control biopsies than optimal, and they were not taken from the uninvolved periorbital region. Conclusion: Mean linear melanocyte density and the ratio of melanocytes to keratinocytes is increased in cases with periorbital hyperpigmentation. It is, therefore, likely that increased melanocyte density may be the key factor in the pathogenesis of periorbital hyperpigmentation.

Cyclosporine in Stevens Johnson syndrome and toxic epidermal necrolysis and retrospective comparison with systemic corticosteroid.

Background: Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening dermatological emergencies. Many immunosuppressive modalities have been tried with variable results. Aims: To determine the efficacy of cyclosporine in cases of SJS and TEN and compare the efficacy with systemic corticosteroid in the same condition. Methods: Study was conducted at a tertiary hospital during 01 July 2011 to 30 June 2012. SCORTEN was assessed at the time of admission. Total body surface area (TBSA) assessment was like any burn patients. Cyclosporine was administered in the dose of 3 mg/kg body weight in three divided dosage for 07 days and then tapered over another 07 days. Data were compared to a historical series of SJS/TEN patients, managed by systemic steroids a year ago. Results: A total of 11 consecutive patients with a mean age of 32.09 and standard deviation (SD 16.17) were enrolled in to cyclosporine group, which were retrospectively compared to 6 patients with a mean age of 27.87 (SD 13.97) years in the corticosteroid group. The mean duration of re-epithelialization was 14.54 (SD 4.08) and 23 days (SD 6.68) in cyclosporine and corticosteroid group respectively (P = 0.009956). Mean hospital stay was 18.09 (SD 5.02) and 26 (SD 6.48) days in cyclosporine and corticosteroid group respectively (P = 0.02597). A total of 1.11 and 0.51 patients were expected to die against no death and two deaths in cyclosporine and corticosteroid group respectively (Standardized mortality ratio = 3.92) (P = 0.04321). Conclusion: This study definitely suggests that cyclosporine has encouraging role in the management of uncomplicated cases of SJS, SJS-TEN overlap or TEN.

Morphometric study of microvessels, epidermal characteristics and inflammation in psoriasis vulgaris with their correlations.

Background: Vascular proliferation, inflammation and epidermal changes are important features in the pathogenesis of psoriasis. Aims: In this study we attempted an objective evaluation of these parameters using morphometry. Methods: Inflammation, microvessels and epidermal parameters were assessed in 50 newly diagnosed cases of psoriasis vulgaris (between 01 Nov 2008 and 31 Oct 2011) by morphometry. Parameters studied were microvessel density, microvessel caliber, inflammatory cell density in dermis, ratio between inner and outer epidermal length, maximum epidermal thickness, minimum epidermal thickness and difference between maximum epidermal thickness and minimum epidermal thickness. Results: Microvessel caliber showed moderate correlation (r = 0.645) and microvessel density, weak correlation (r = 0.226) with inflammatory cell density in dermis. Both these parameters also showed mild positive correlation with "ratio between inner and outer epidermal length". All parameters except minimum epidermal thickness showed mild positive correlation with inflammatory cell density in dermis. Conclusion: All microvessels and epidermal parameters showed positive correlation with dermal inflammation; and epidermal parameters exhibited positive correlation with micro-vascular dilation. It is likely that inflammation is a key factor in the pathogenesis of psoriasis.

Topical corticosteroid abuse on the face: A prospective, multicenter study of dermatology outpatients .

Background: Abuse of topical corticosteroids (TC), especially over the face, is prevalent worldwide, including in India. Data about the magnitude of this problem in our country is lacking. Aims: The aims of this study were to ascertain the demographics, magnitude and clinical features of TC misuse on the face in the dermatology outpatient department (OPD) attendees in order to raise awareness about this problem and to analyze its causes. Methods: This was a prospective multicenter questionnaire-based clinical study conducted at 12 dermatology centers nationwide. Patients with relevant facial dermatoses reporting to the investigator were asked about their current use of over-the-counter topical formulations and a structured questionnaire applied in case the same was confirmed to be TC. Results: A total of 2926 patients with facial dermatoses were screened, of which 433 (14.8%) were using TC. TC was used as a fairness/general purpose cream or aftershave in 126 (29%) and in 104 (24%) for acne. Steroid combinations were used by 258 (59.6%). Potent and super-potent TC were significantly (P = 0.05) more frequently used by the rural/suburban population. The younger age groups used more potent formulations. A non-physician recommendation for TC use was obtainable in 257 (59.3%) patients. Of these, 232 (90.3%) were for potent/super-potent steroids. Among 176 physician prescriptions, 78 (44.3%) were from non-dermatologists. All non-physician prescriptions and 146 (83%) physician prescriptions for TC were inappropriately refilled. Adverse effects were seen in 392 (90.5%) TC users. Acne/exacerbation of acne was the most common adverse effect. Conclusions: TC misuse in patients with facial dermatoses is quite common, and most of this use is unwarranted. Use as a fairness cream is the most common indication in this cohort. Limitations: This was an OPD-based study and, therefore, it may or may not accurately reflect the community data.

Extramammary Paget's disease.

Two patients with extramammary Paget's disease are being reported. The first case was a 60-year-old male who presented with gradually progressive pruritic ulcerated lesion over perianal region not responding to various topical medications. Dermatological examination revealed a large erythematous sharply marginated scaly plaque in the perianal region extending into the anal canal, covered with grayish crusts and shallow erosions. Skin biopsy from the lesion was suggestive of Paget's disease. The second patient, a 60-year-old male, with a three year long history, presented with similar lesions and findings. Skin biopsy in this case was also consistent with Paget's disease. These two cases of extramammary Paget's disease involving the perianal region are being reported because of their rarity and also to stress the fact that a high degree of suspicion is needed for the diagnosis of this uncommon disease entity.

Painful bruising syndrome.

Painful bruising syndrome is a distinctive but rare clinical entity. A case of this condition in a psychiatrically normal teenage girl is reported.