Clinical evaluation of a topical Unani pharmacopoeial formulation Tila-e-Kalf in the management of melasma (Kalf): A randomized controlled clinical trial.

Objective: Melasma is a chronic, acquired, symmetrical hyper melanosis of skin, characterized by irregular light to dark brown patches on sun-exposed areas, with a significant effect on psychological health; melasma is termed as Kalf in Unani medicine. Conventional treatments have transitory results and often carry adverse effects like skin irritation, scarring, etc. This study was planned to evaluate the safety and efficacy of a Unani pharmacopoeial formulation Tila-e-Kalf, comprising of lentil (Lens culinaris), bitter almond (Prunus amygdalus), and fig (Ficus carica), and to compare its efficacy with standard drug hydroquinone in patients of melasma. Materials and Methods: This was an 8-week open-label, standard controlled, randomized clinical study conducted on patients of epidermal melasma. The test group received Tila-e-Kalf while the control group received hydroquinone 4% cream for local application once daily. Efficacy was assessed by MASI (Melasma Area Severity Index), DLQI (Dermatology Life Quality Index), and PGA (Physician Global Assessment) and colored photographs. Results: Mean MASI score decreased from10.65±0.85 to 7.07±0.74 in the test group (p<0.0001) and from 11.28±1.24 to 7.76±0.9 (p<0.0001) the in control group. Similar improvement was noticed in other parameters also. A large number of patients in the control group reported mild burning, itching, dryness, and skin rashes, while only one patient in the test group reported mild itching. Conclusion: Tila-e-Kalf as a topical depigmenting agent was found equally effective with better tolerability and safety as compared to hydroquinone.

Pharmacokinetic and clinical comparison of super-bioavailable itraconazole and conventional itraconazole at different dosing in dermatophytosis.

Background: Due to changing face of dermatophytosis in India, many dermatologists practice different dosing patterns of itraconazole (ITZ). Recently, a new form of ITZ, super-bioavailable ITZ (SBITZ), has been commercialized to overcome the pharmacokinetic challenges of conventional ITZ (CITZ). Serum and sebum concentration of ITZ plays an important role in the management of dermatophytosis. Hence, the current study compares the rate and extent of serum and sebum concentration of SBITZ and CITZ at different dosing to determine their efficacy and safety in patients with dermatophytosis. Methods: This was an open-label, randomized, four-arm study including 40 adult patients diagnosed with glabrous tinea who were randomized equally into four groups to receive either CITZ-100-BD or CITZ-200-OD (2×100 mg capsules) or SBITZ-130-OD or SBITZ-100-OD (2×SBITZ-50 mg capsules) for 4 weeks. Serum and sebum samples were analysed at different time intervals along with clinical efficacy and safety. Results: For serum concentration, on day 28, the arithmetic mean and standard deviation (SD) for CITZ-100-BD, CITZ-200-OD, SB-130-OD and SB100-OD were 1262±233.5 ng/mL, 1704±261.6 ng/mL, 1770±268.9 ng/mL and 1520±231.7 ng/mL, respectively, which was statistically significant for OD dosing of ITZ/SBITZ over CITZ-100-BD. Similarly, for sebum concentration, the arithmetic mean and SD for CITZ-100-BD, CITZ-200-OD, SB-130-OD and SB-100-OD were 1042±163.45 ng/mg, 1423±192.46 ng/mg, 1534±227.55 ng/mg and 1107±182.35 ng/mg, respectively, which was statistically significant for SB-130-OD and CITZ-200-OD over CITZ-100-BD and SBITZ-100-OD dosing. No significant difference was noted between SBITZ-130 and CITZ-200 (p=0.25). Only two patients achieved complete cure in the SBITZ-130 group, whereas no patients achieved the same in other groups (p=0.47). All the dosages were very well tolerated with only 12 adverse events reported by ten patients in all groups. Conclusion: All formulations achieved desired serum and sebum concentrations required for efficacy in dermatophytosis, but SB 130 mg OD and CITZ 200 mg OD were statistically significant than other ITZ doses in achieving sebum concentration. Additionally, SBITZ 130 mg OD was bioequivalent to CITZ 200 mg OD and achieved similar results to those of CITZ 200 mg OD but at 35% lower drug concentrations.

A comparative study of topical tacrolimus and topical triamcinolone acetonide in nodular scabies.

The aim of this study was to compare the efficacy and safety of 0.1% triamcinolone acetonide and 0.03% tacrolimus ointment for the treatment of nodular lesions of scabies. In this double-blind randomized controlled trial, 50 Indian men with postscabeitic persistent nodular lesions (labelled to have nodular scabies (NS)/postscabies prurigo (PSP)) over the external genitalia, were enrolled. They were randomized into two groups to receive either a mid-potency topical corticosteroid (TCS); triamcinolone acetonide 0.1% ointment twice daily, or topical calcineurin inhibitor (CNI); tacrolimus ointment 0.03% twice daily over the nodular lesions for 2 weeks. All patients were followed up on three visits: 1, 2, and 6 weeks, for assessment. Efficacy was evaluated by 5-point range investigator-assessed VAS, and a 4-point severity of pruritus scale (SPS) score. The mean VAS score was higher in triamcinolone group compared to tacrolimus group at both follow-ups, although statistically significant only at 2nd week visit. The fall in mean SPS at both follow-ups was also higher in the steroid group, but the difference was not statistically significant. While, the overall tolerance to either ointment was excellent, mild hypopigmentation, and epidermal atrophy were detected on dermoscopic evaluation of the treated areas at the 2nd week visit in a small subset of patients in the triamcinolone group. The frequency of relapse of lesions and/or pruritus after four weeks of the 2-week therapy was high in both the groups (higher in tarolimus group). Conclusively, although both treatment options provided safe and satisfactory short term improvement, the results from this study suggest an overall higher efficacy of a mid-potency TCS like triamcinolone 0.1% over topical CNI like tacrolimus 0.03%, in the short-term treatment of nodular lesions of NS/PSP. Topical CNIs may be considered for maintenance of effect, if prolonged therapy is warranted.

Efficacy of oral zinc therapy in epidermodysplasia verruciformis with squamous cell carcinoma.

Epidermodysplasia verruciformis (EV) is a rare, inherited disorder that predisposes patients to widespread human papillomavirus (HPV) infection and cutaneous squamous cell carcinomas. There is still no definitive therapeutic modality for EV. A 24 year old male patient with EV was treated with oral zinc sulphate, one of the cheapest and safe immuno-modulator available as therapeutic agent with satisfactory result.

Which type of atrophic acne scar (ice-pick, boxcar, or rolling) responds to nonablative fractional laser therapy?

BACKGROUND: Few studies have examined the role of fractional lasers in individual acne scars (ice-pick, box car, rolling) using objective assessment tools in darkly pigmented skin. OBJECTIVE: To evaluate the effect of 1,540-nm fractional lasers on individual acne scars. METHODS AND MATERIALS: A prospective interventional study was conducted in 35 patients using a 1,540-nm fractional laser. Six sessions were performed with four passes per session and a dose varying from 70 to 100 mJ to maximize the DWR. A self-devised objective assessment tool with dose settings to optimize the depth-to-width ratio (DWR) and a visual analog scale (VAS) were used to count individual atrophic scars. Final results were assessed 6 months after final laser treatment. RESULTS: Acne scar reduction efficiency was used to validate the improvement of individual scars, a meaningful difference was considered as 51% or greater improvement. The boxcar scars (52.9%) responded better than the rolling (43.1%) and ice-pick scars (25.9%), with statistically significant improvement (p < .05) seen in boxcar scars after four sessions. Overall VAS scores revealed significant improvement (p < .001). CONCLUSION: Using an objective evaluation tool, an erbium-doped glass laser was found to improve atrophic acne scars, markedly so for boxcar and rolling scars. The VAS score overestimated improvement because of its subjective nature.