Comparative study of efficacy and safety of cetirizine and bilastine in patients of chronic spontaneous urticaria: Open-label, randomized, parallel-group study.

Purpose: Bilastine is a novel second-generation antihistaminic. Very few studies in Indian population have compared the safety and efficacy of bilastine with other second-generation antihistaminic like cetirizine. Hence, the present study was planned. Materials and Methods: This was a randomized, open-label comparative parallel group study conducted on 70 patients of chronic spontaneous urticaria (CSU). Patients either received cetirizine 10 mg or bilastine 20 mg once daily for 6 weeks. The primary endpoint was to find out the difference in the mean total symptom score (MTSS) at baseline and 6 weeks. The secondary endpoint was to find out changes in the scale of the number of wheals, change in pruritus scale, scale for size of wheal, change for interference of wheals with sleep, change in visual analog scale (VAS) for sedation, change in scale for intensity of erythema, and change in Scale for Extent of Skin Area Involvement (SESI). Results: Bilastine and cetirizine offer a significant reduction in MTSS, mean number of wheals, and mean pruritus scale at baseline to 1, 3, and 6 weeks. The mean difference in MTSS was significantly more in bilastine. Cetirizine showed a significant increase in VAS score for sedation as compared to bilastine. Both the drugs were well tolerated and safe. Adverse events like headache, gastric irritation, dryness of mouth, and sedation were more reported in cetirizine group. Conclusion: Bilastine was more efficacious than cetirizine in patients of CSU and the efficacy was seen earlier at 1 week, which was not seen in the cetirizine group.

Uncommon Presentation of Leprosy: A Report of Two Cases.

Lazarine leprosy is an unusual expression of usually borderline tuberculoid (BT) form characterized by spontaneous ulceration of skin lesions. This is presumably the result of an exaggerated type 1 reaction. It commonly occurs in the BT, borderline lepromatous forms and rarely in the lepromatous forms of leprosy. We report two cases of lazarine leprosy in the BT and BT downgrading to borderline lepromatous spectrum in healthy and immunocompetent males.

Comparative evaluation of efficacy and tolerability of apremilast and methotrexate in patients of moderate-to-severe palmoplantar psoriasis: A randomized, parallel, open-label clinical trial.

BACKGROUND: Variable results about efficacy as well as safety of apremilast compared to methotrexate are reported in different trials. Hence, it is necessary to collect more evidence to prove the role of Apremilast in palmoplantar psoriasis. METHODOLOGY: The study was a randomized, prospective, parallel-group, open-label study conducted in patients with moderate-to-severe palmoplantar psoriasis. They were randomized into two groups, methotrexate (n = 19) or apremilast (22) for 16 weeks. Primary efficacy parameter was reduction in modified palmoplantar psoriasis area and severity index (mPPPASI) score from week 0 to week 16. Other parameters were proportion of patients attaining Static Physician Global Assessment score of 0 (clear) or 1 (almost clear), proportion of patients attaining mPPPASI75 (75% reduction in mPPPASI score) at the end of 16 weeks, and proportion of patients showing at least 5-point decline in dermatology life quality index from baseline. RESULTS: Decline in m-PPPASI score from 0 week to 16 weeks within the group was significant statistically though decline in score of m-PPPASI between these two groups was not statistically significant at 16 weeks. Similar results were obtained with the secondary efficacy parameters. In methotrexate group, there were 24 adverse events recorded including abnormal liver function tests in three patients. In apremilast group, 19 adverse events were recorded, in which two patients suffered from upper respiratory tract infection. CONCLUSION: Apremilast is as effective as methotrexate for the management of moderate-to-severe palmoplantar psoriasis with better tolerability. Hence, it can be considered alternative to established drugs in patients having palmoplantar psoriasis not responding to or tolerating other drugs. REGISTRATION: The study was registered with Clinical Trial Registry of India (CTRI/2020/05/025198).

Clinico-investigative Study of Facial Acanthosis Nigricans.

Background: Facial acanthosis nigricans (FAN) is an underrecognized and underdiagnosed entity. The typical presentation of acanthosis nigricans (AN) seen elsewhere on the body like axillae and groins is not seen on the face, making it mimic other pigmentary disorders. Moreover, FAN is seldom not accompanied with AN on the classical sites making the diagnosis challenging. The aims of this study were to determine clinical, dermoscopic, and histopathological features of FAN and to estimate the prevalence of obesity and insulin resistance (IR) in FAN. Methods: Forty cases of FAN and forty healthy nonobese individuals with comparable ages and gender were included in the study. Body mass index, waist circumference, hip circumference, waist to hip ratio, and serum fasting lipid levels were used to evaluate obesity, whereas serum fasting insulin and Homeostatic Model of Assessment of Insulin Resistance (HOMA-IR) were used to evaluate IR. Dermoscopy was performed in all cases. Histopathological features of the skin biopsies were reviewed. Results: Out of the 40 cases, 24 were male and 16 were female. The patterns of facial pigmentation in addition to the classic pattern were a hyperpigmented band over forehead (55%), periorbital darkening (25%), perioral (10%), and generalized darkening (10%). Dermoscopy in all cases revealed linear crista cutis, sulcus cutis, and hyperpigmented dots in crista cutis. Biopsy of 20 cases showed mild hyperkeratosis, acanthosis, papillomatosis, and increase in basal melanin. Clinico-dermoscopic-histological correlation showed that milder (light brown) variants of FAN had follicular plugging and subtle sulci pattern with irregular brown globules and perifollicular pigmentation on dermoscopy and mild hyperkeratosis and hypermelanization of the basal layer with minimal acanthosis and papillomatosis on histopathology. On the other hand, chronic variants (dark brown and black) showed prominent sulci, larger brown globules, and perifollicular hyperpigmentation on dermoscopy and moderate hyperkeratosis and hypermelanization of the basal layer with moderate to severe acanthosis and papillomatosis on histopathology. Fasting blood glucose, insulin, HOMA-IR, fasting serum triglyceride, and total cholesterol were statistically significantly high in cases in comparison with controls (P-value <0.05). Conclusions: Varied clinical presentations of FAN were observed. Dermoscopy and histopathology provide a good aid. FAN may be considered as a cutaneous marker of obesity and IR. Thus, FAN should be suspected in patients presenting with facial melanosis who are obese and have AN over other sites, although FAN can also present de novo.

Comparison of efficacy, safety, and cost-effectiveness of sertaconazole and luliconazole cream in patients with dermatophytoses: A prospective, randomized, open-label study.

OBJECTIVE: To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses. MATERIALS AND METHODS: Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open-label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit. RESULTS: The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly (P < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group (P = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis. CONCLUSION: Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole.

Dowling-Degos Disease with Follicular Involvement Associated with Hidradenitis Suppurativa: A Manifestation of Follicular Occlusion Phenomenon?

A 30-year-old female patient presented with progressive reticulate pigmentation of the neck, upper chest, back, cubital fossa, and axillae since the age of 15 years. The patient also complained of recurrent multiple tender nodules and plaques associated with sinuses and pus discharge over the axillae, groins, and buttocks which healed with scarring for 4 years. There were multiple pitted scars and hyperpigmented macules over the perioral area and cheeks. Scattered comedo-like lesions were present over the upper back, chest, cubital fossae, and buttocks. Histopathology from the pigmented lesion revealed thinning of the suprapapillary epidermis, epidermal hyperplasia with finger-like elongation of the rete ridges, and increased pigmentation of their lower part, suggestive of Dowling-Degos disease (DDD). Biopsy section from comedonal lesion showed dilated infundibulum and antler-like rete ridges suggestive of follicular DDD. We report a case of DDD with follicular involvement and hidradenitis suppurativa (HS) which is a rare association and can be explained on the basis of single underlying defect in follicular epithelial proliferation. DDD-HS has been shown to result from mutations in PSENEN, encoding a critical component of the γ-secretase complex.

Congenital atrichia with papular lesions.

Congenital atrichia with papular lesions is a rare, autosomal recessive and irreversible form of total alopecia of the body hair characterized by hair loss soon after birth and the development of keratinfilled cysts or horny papules over extensive areas of the body. The condition is associated with a mutation of the human hairless gene on chromosome region 8p12. We report a 1-year-old boy presenting with the absence of scalp and body hair since birth. On examination, he had complete absence of hair on the scalp, eyebrows, and eyelashes. Multiple, discrete, pearly-to-skin-colored papules of 1-3mm in size were present over the scalp. The skin biopsy from a scalp papule revealed normal overlying epidermis with multiple keratin cysts and hypoplastic hair follicles in the upper dermis.

Nevus Lipomatosus Cutaneous Superficialis - A Rare Hamartoma: Report of Two Cases.

Nevus Lipomatosus Cutaneous Superficialis (NLCS) is a rare benign hamartomatous disorder in which mature collection of adipocytes are present ectopically in the dermis. NLCS usually presents as multiple, soft, pedunculated, cerebriform, yellowish or skin colored papules, nodules, or plaques, mostly involving the pelvic or gluteal region. We herewith report two cases of adult onset classical NLCS. First case had a classical presentation with lesion on lower back while second case was associated with some unusual features like occurrence on pubic area and associated comedo-like lesions.

Efficacy and tolerability of topical fixed combination of nadifloxacin 1% and adapalene 0.1% in the treatment of mild to moderate acne vulgaris in Indian patients: a multicenter, open-labelled, prospective study.

BACKGROUND: A combination of topical retinoid and antibacterial therapy is often advocated for acne to enhance therapeutic efficacy. AIMS: A preliminary study to evaluate the efficacy and tolerability of a topical fixed combination of nadifloxacin (1%) and adapalene (0.1%) in the treatment of mild to moderate acne in Indian patients. MATERIALS AND METHODS: This was an open-labeled, phase 3 non-randomized, non-comparative study conducted at five centers (Ahmedabad, Nagpur, Thane, Bangalore, and Mumbai) across India. Of 119 enrolled patients with mild to moderate acne, 117 patients were evaluated at the end of the study for efficacy parameters. A fixed combination of nadifloxacin (1%) and adapalene (0.1%) topical gel was applied at the affected area once at night for a period of 8 weeks. Reduction in the total, inflammatory and non-inflammatory lesion counts from the baseline, investigator global assessment (IGA) and reduction in the severity of acne as per combined acne severity classification were the primary efficacy variables measured at 2 weeks, 4 weeks, and 8 weeks. RESULTS: Overall, 98.3% patients showed a statistically significant progressive reduction in non-inflammatory lesion counts, inflammatory lesion counts, and total lesion counts over the study duration. By the end of 8 weeks, 75% of the patients had their global assessment scores approaching to normal healthy skin score. The adverse events were mild to moderate in severity. CONCLUSION: This preliminary study shows that a fixed combination of 1% nadifloxacin and 0.1% adapalene topical gel could be an effective and well-tolerated option for the treatment of mild to moderate acne vulgaris. However, further well-controlled, randomized and comparative evaluation of this combination is necessary.