Real-World, Non-Interventional, Observational Study of Hydroxyzine Hydrochloride in Chronic Pruritus: a Prospective, Non-Comparative Study.

INTRODUCTION: Although hydroxyzine is widely used for symptom relief in pruritus, its clinical safety and efficacy data in the Indian setting are scarce. We conducted a study to assess the effectiveness and tolerability of hydroxyzine in the management of Indian patients with chronic pruritus in a real-world setting. METHODS: This was a prospective, observational, patient-reported outcomes (PRO) study in patients with chronic pruritus due to dermatological causes treated with hydroxyzine as per the clinician's discretion for a period of up to 12 weeks. The primary outcome was improvement in quality of life from baseline, assessed using the 10-point Dermatology Quality of Life Index (DLQI) at week 12 of the study period. Secondary outcomes were improvement in the pruritus scores (5-D itch scale) at 12 weeks, improvements in the DLQI and 5-D itch scores at 2, 4 and 8 weeks and safety. RESULTS: The study included 400 patients (179 males, 221 females) from 7 dermatology centres across India. Of the 400 patients recruited, 391 patients completed at least 2 weeks of treatment. There was significant (p < 0.0001) improvement from baseline in the DLQI scores and 5-D itch scores at 2, 4, 8 and 12 weeks; 189/391 (48.34%) patients had symptom relief leading to early termination. Overall, the treatment was well tolerated with a total of 11 mild-to-moderate adverse events reported during the study, which included dizziness, constipation, drowsiness, dry mouth and sedation. All events resolved without any intervention. There were no serious adverse events. CONCLUSION: This real-world, observational, PRO study demonstrates that hydroxyzine significantly improves symptoms of pruritus and quality of life in patients with chronic pruritus due to dermatological causes over 12 weeks. Despite the sedating potential of the drug, hydroxyzine is well tolerated in real-world settings. TRIAL REGISTRATION: CTRI/2017/06/008847. FUNDING: Dr. Reddy's Laboratories.

Multiple Cutaneous Reticulohistiocytoma.

Multicentric reticulohistiocytosis is a rare non-Langerhans cell histiocytosis characterized in its full form by severe destructive arthritis, cutaneous nodules, and systemic manifestations. Cutaneous lesions may precede, accompany, or more commonly develop later than other features in this disease. We describe a case of multiple cutaneous reticulohistiocytoma without any systemic associations after thorough investigations.

Giant cell tumor of the tendon sheath mimicking a plexiform neurofibroma.

Giant-cell tumor of the tendon sheath (GCTTS) is a benign soft tissue tumor of the limbs arising from the complex of the tendon sheath and periarticular soft tissues of small joints. It is the second most common benign space occupying lesion in the hand and usually presents as a painless soft tissue mass, which grows slowly in size for many years. We present an interesting case of an enormous GCTTS presenting as a slowly growing mass over left sole of a 52-year-old woman. The duration of GCTTS may range from a few weeks to 30 years but in our case the duration of tumor was almost 48 years, which could be the longest reported duration of GCTTS.

Perplexing purpura in two females: Rare case of autoerythrocyte sensitization syndrome.

Autoerythrocyte sensitization syndrome is a psychologically induced painful bruising condition. Two female, 19 and 30-year-old presented with recurrent episodes of painful ecchymotic bruising over accessible areas of body. In the younger female, episodes were since 3 years and were precipitated by stress and trivial trauma. The elder female presented with similar lesions since 3 months which were spontaneous in presentation. There were no obvious psychiatric manifestations in either. Clinically, ecchymotic changes in various stages of development were seen. Routine hemogram and coagulation profile were normal. Histopathology showed extravasated erythrocytes, perivascular neutrophils and fibrinoid deposition. Intradermal injection of autologous whole blood produced a painful ecchymotic reaction after 2 h similar to the presenting lesions. Psychiatric evaluation revealed mild mixed depression - anxiety disorder in the younger female while the latter revealed no abnormalities. The diagnosis of autoerythrocyte sensitization syndrome was made based on clinical history and findings, positive autoerythrocyte sensitization test, psychiatric evaluation and absence of any other clinical or laboratory pathology.

Dermatomyositis associated with malignancy: A report of 3 cases.

The association between dermatomyositis (DMS) and various types of malignancies has been reported in several studies, with an estimated frequency of 20-25%. DMS may precede, accompany or follow the diagnosis of malignancy. In the present report, we have discussed three cases of dermatomyositis associated with malignancy. In the first case, DMS preceded the diagnosis of gastric adenocarcinoma while in the second and third cases, it followed the diagnosis of ductal carcinoma of the breast and transitional cell carcinoma of the bladder respectively. In all three patients, cutaneous and musculoskeletal features of DMS showed very good response to the treatment, irrespective of the course of malignancy.

Evaluation of Efficacy, Safety, and Tolerability of Fixed Dose Combination (FDC) of Halometasone 0.05% and Fusidic Acid 2% W/W Topical Cream Versus FDC of Betamethasone Valerate 0.12% and Neomycin Sulphate 0.5% W/W Topical Cream in the Treatment of Infected Eczematous Dermatosis in Indian Subjects: A Randomized Open-Label Comparative Phase III Multi-Centric Trial.

AIM: To evaluate the efficacy and safety of fixed drug combination (FDC) halometasone 0.05% and fusidic acid 2% (group A) vs FDC betamethasone 0.12% and neomycin sulfate 0.5% cream (group B) in acute or chronic infected eczematous dermatosis, through a randomized open-label, comparative, multicentric study. MATERIALS AND METHODS: A total of 152 patients were randomized to either Group A or Group B. EASI (Eczema Area and Severity Index), IGA (Investigator's global assessment), scale for severity of eczema, pruritus, and safety parameters were assessed at baseline, Day 5/Day 10, Day 10/20, and Day 20/Day 30 for acute/chronic cases. Skin swabs were tested at screening, Day 10, and end of the study. RESULTS: Staphylococcus aureus was the frequently encountered causative agent. There was a significant reduction within the study groups in EASI, IGA scales for severity of eczema, pruritus at various visits, compared to baseline. At the end of study, 83.87% in group A and 65.71% in group B were culture negative. Cure rate was 54.28% and 50% in group A and B, respectively. Five adverse events were reported in five patients, of which three patients withdrew from the study. CONCLUSION: Halometasone 0.05% and Fusidic acid 2% cream is effective, safe, well tolerated with comparable efficacy to the comparator in the treatment of acute and chronic infected eczematous dermatosis.

Adenoid type of Basal cell carcinoma: rare histopathological variant at an unusual location.

Basal Cell Carcinoma (BCC) is almost exclusively seen in head-neck region with rare involvement of trunk and extremities. The tumour is commonly seen on nose, eyelids, at the inner canthus of eyes and behind the ears. Adenoid type of BCC is one of the rare histopathological types of BCC which has not found to have any site predilection. We report two cases of BCC occurring at an unusual site i.e., lower back and both of them showed adenoid type of BCC on histopathology. Morphologically they were pigmented and ulcerative type of BCC respectively.

Is there a role for rifampicin, ofloxacin and minocycline (ROM) therapy in the treatment of leprosy? Systematic review and meta-analysis.

BACKGROUND: A combination of rifampicin, ofloxacin and minocycline (ROM) is one of the newer recommendations for treatment of leprosy. We performed a systematic review and a meta-analysis of studies that had evaluated the efficacy of ROM therapy in treatment of paucibacillary and multibacillary leprosy patients. METHODS: Studies were identified by searching the PubMed, Embase, LILACS and Cochrane databases. Data were abstracted from all relevant studies, and fixed effects models were used to calculate the summary estimate of effect in paucibacillary and multibacillary leprosy patients. RESULTS: Six studies comparing ROM therapy to multidrug therapy and eight studies that evaluated the effect of ROM therapy alone (no comparison group) were included in the review and meta-analysis. The combined estimate for single dose ROM vs. multidrug therapy in paucibacillary leprosy patients suggested that ROM was less effective than multidrug therapy in these patients [relative risk: 0.91, 95% confidence intervals (CI): 0.86-0.97]. However, the combined estimate for multiple doses of ROM vs. multidrug therapy in multibacillary leprosy patients suggested that ROM was as effective as multidrug therapy in reducing bacillary indices in these patients (proportion change: -4%, 95% CI -31% to 23%). No major side effects were reported in either the ROM or the multidrug treatment groups. CONCLUSIONS: Single-dose ROM therapy was less effective than multidrug therapy in paucibacillary patients. However, there are insufficient data to come to a valid conclusion on the efficacy of multidose ROM therapy in multibacillary leprosy, and additional studies with ROM therapy in multibacillary leprosy are needed. Furthermore, multiple doses may be considered as another alternative even for paucibacillary patients, and randomised controlled trials of this therapy may be useful to understand its contribution in the treatment and control of leprosy.

Married men who have sex with men: the bridge to HIV prevention in Mumbai, India.

OBJECTIVES: The present study compared the sexual behaviours of married and unmarried men, in Mumbai, India, who have sex with men. METHODS: We conducted a cross-sectional analysis (comparing socio-demographic, behavioural and clinical data) of 88 married and 423 unmarried MSM. RESULTS: Even though MSM are single at younger ages, they are more likely to be married later in life and carry their risky sexual behaviours to this changed social milieu. CONCLUSIONS: Married MSM had high-risk behaviours with both men and women; they form an important intervention group for HIV prevention. The interventions will not only reduce the transmission in the male-to-male sexual group, but will also have an effect on the male-to-female transmission of HIV.

Clinical and demographic trends in a sexually transmitted infection clinic in Mumbai (1994-2006): an epidemiologic analysis.

BACKGROUND: People presenting to sexually transmitted infections (STIs) clinics represent an important risk group for HIV infection; prevention strategies will depend on the clinical attendance. AIMS: The demographic and clinical changes in clinic attendees in Mumbai, as well as the factors associated with HIV infection in this clinic over a 13-year period, were assessed. METHODS: STI clinic data in 3417 individuals (1994 to 2006) were analyzed: clinical presentation, types of STIs, and serology over the 13-year period. We used a logistic regression model to assess socio-demographic and clinical associations with HIV infection. RESULTS: The clinic evaluated 689 patients in 1994 and the number had dropped to 97 in 2006. In 1994, the majority of STIs seen in the clinic were bacterial (53%, 95% confidence interval [CI] 50% to 57%); however, this proportion had dropped in 2006 (28%, 95% CI: 19% to 38%). There was a proportional increase in viral STIs during the same time period. Although women attending the clinic were younger than men, they were more likely to be married. The overall seropositivity for HIV was 28%. Viral STIs were more likely to be associated with HIV than bacterial infections (odds ratio: 1.5, 95% CI: 1.2 to 1.9). CONCLUSIONS: Viral infections were the most common STIs in recent years in a tertiary care center in Mumbai. HIV prevalence was high in this population. Thus, these clinical data suggest that STI patients were and continue to be an important group for HIV prevention in the country.

The effects of a daily facial lotion containing vitamins B3 and E and provitamin B5 on the facial skin of Indian women: a randomized, double-blind trial.

BACKGROUND: The B vitamins niacinamide and panthenol have been shown to reduce many signs of skin aging, including hyperpigmentation and redness. AIMS: To measure the facial skin effects in Indian women of the daily use of a lotion containing niacinamide, panthenol, and tocopherol acetate using quantitative image analysis. METHODS: Adult women 30-60 years of age with epidermal hyperpigmentation were recruited in Mumbai and randomly assigned to apply a test or control lotion to the face daily for 10 weeks. Effects on skin tone were measured using an image capturing system and associated software. Skin texture was assessed by expert graders. Barrier function was evaluated by transepithelial water loss measurements. Subjects and evaluators were blinded to the product assignment. RESULTS: Of 246 women randomized to treatment, 207 (84%) completed the study. Women who used the test lotion experienced significantly reduced appearance of hyperpigmentation, improved skin tone evenness, appearance of lightening of skin, and positive effects on skin texture. Improvements versus control were seen as early as 6 weeks. The test lotion was well tolerated. The most common adverse event was a transient, mild burning sensation. CONCLUSIONS: Daily use of a facial lotion containing niacinamide, panthenol, and tocopheryl acetate improved skin tone and texture and was well tolerated in Indian women with facial signs of aging.

Alopecia in congenital hidrotic ectodermal dysplasia responding to treatment with a combination of topical minoxidil and tretinoin.

Clouston's syndrome is an ectodermal dysplasia characterized by dystrophic nails, alopecia, and palmoplantar hyperkeratosis. Alopecia is due to decrease in number and degree of maturation of the hair follicles. Tretinoin is a mitogen by itself and also enhances the absorption of minoxidil which acts by enlarging the miniaturized hair follicles. We report a case of alopecia in Clouston's syndrome who responded to treatment with topical minoxidil and tretinoin.