Clinical Use of Super Bioavailable Itraconazole for the Management of Dermatophytosis: Consensus Statement by Dermatologists from India via the Modified Delphi Technique.

INTRODUCTION: Super bioavailable itraconazole (SB ITZ) overcomes the limitations of conventional itraconazole (CITZ) such as inter-individual variability and reduced bioavailability. It has been approved for systemic mycoses in Australia and Europe as 50mg and the United States as 65mg and in India as 50mg, 65mg, 100mg, and 130mg. However, data on the ideal dose and duration of SB ITZ treatment in managing dermatophytosis is insufficient. This consensus discusses the suitability, dosage, duration of treatment, and relevance of using SB ITZ in managing dermatophytosis in different clinical scenarios. METHODS: Sixteen dermatologists, (>15 years of experience in the field and ≥2 years clinical experience with SB ITZ) formed the expert panel. A modified Delphi technique was employed, and a consensus was reached if the concordance in response was >75%. RESULTS: A total of 26 consensus statements were developed. The preferred dose of SB ITZ is 130mg once daily and if not tolerated, 65mg twice daily. The preferred duration for treating naïve dermatophytosis is 4-6 weeks and that for recalcitrant dermatophytosis is 6-8 weeks. Moreover, cure rates for dermatophytosis are a little better with SB ITZ than with CITZ with a similar safety profile as of CITZ. Better patient compliance and efficacy are associated with SB ITZ than with CITZ, even in patients with comorbidities and special needs such as patients with diabetes, extensive lesions, corticosteroid abuse, adolescents, and those on multiple drugs. CONCLUSION: Expert opinions indicate that overall clinical experience with SB ITZ is better than that with CITZ.

Practical Aspects of Acne Scar Management: ASAP 2024.

Acne scars are one of the most common complications of acne. They can significantly affect the patient's quality of life. Often, several types of atrophic acne scars are observed simultaneously; therefore, consideration must be given to the type of scar while choosing the treatment modality. Effective treatment is not only important to prevent and improve acne scars but also crucial in preventing psychosocial effects. Treatment of acne scars requires an algorithmic approach that targets each component of the scars, and combination therapy on a patient-specific basis may offer the best chance for significant improvement. The goal of the current article is to discuss the practical aspects of management of atrophic acne scars using the vast modalities of treatment available. The panel of dermatologists and plastic surgeons, each one with at least 20 years of experience in acne scar treatment, participated in a series of 'Practical Aspects of Acne Scar Management' (ASAP) meetings: ASAP 2024. ASAP meetings were organized by "Scar Forum India" from March 2023 to July 2023 in four Indian cities (Mumbai, Delhi, Bengaluru, and Kolkata), each one for a duration of at least three hours. During these meetings and discussions, panelists reviewed and discussed the acne scar-related literature, their clinical experience in its management, available treatment options, along with recent advances. Consequently, a summary of the discussion and practical approach for the management of acne scars is developed. It was concluded that, though there is no specific guideline available to optimize acne scar management despite the multitude of treatment options, the best results can be achieved through the synergy of multiple treatment modalities and using the algorithmic approach.

Oral Tranexamic Acid for the Treatment of Melasma: Evidence and Experience-Based Consensus Statement from Indian Experts.

Melasma, a chronic pigmentary skin condition mainly affecting the face, remains a challenge despite the availability of several options for treatment. Many melasma patients are not satisfied with treatment outcomes. Tranexamic acid (TXA), an anti-fibrinolytic drug has shown promising results in patients with melasma. Evidence from several clinical studies has surfaced on efficacy and tolerability of TXA in these patients. It can be used as monotherapy or adjuvant with other therapies. Currently, there is no published consensus or guideline document for its use in the treatment of melasma. TXA is available for oral use, topical use as well as an injection. In this article, a consensus of Indian experts is prepared based on the available literature and experience with use of oral TXA in melasma. This review article might help clinicians for use of oral TXA appropriately while treating melasma.

Prospective Efficacy and Safety Study of an Innovative Kerascalp Hair Growth Serum in Mild-to-Moderate Alopecia in India: Regrowth Study.

BACKGROUND AND AIM: Male and female pattern baldness, commonly known as androgenetic alopecia is the most common type of alopecia, often predetermined genetically, which generally affects the scalp and is characterized by progressive terminal hair loss, known as miniaturization. This study aimed to assess the safety and efficacy of Kerascalp hair serum, a unique combination of esculin, ximenynic acid, and lauric acid, extracted from natural sources in subjects with mild to moderate androgenetic alopecia. METHODS: An open-label, single-arm clinical study was conducted on healthy males and females aged 18-60 years. Each subject applied the hair serum once daily for 90 days. The efficacy of hair serum was evaluated in terms of the following outcome variables: anagen and telogen ratio (A:T ratio), hair thickness, hair density, hair fall, and hair strength assessment. Subjects were assessed on day 0, day 30, day 60, day 90, and on follow-up day 120. RESULTS: Thirty subjects completed all assessment visits. After using the hair serum for 90 days, statistically significant (p<0.0001) improvement was observed in A:T ratio, hair density, hair thickness, and hair strength; a statistically significant reduction (p<0.0001) in hair fall was also observed. Moreover, improvement in general appearance of hair (in terms of hair volume and density) and scalp (in terms of itchiness, redness, roughness, and dryness) was recorded through dermatological assessment at each treatment visit and at follow-up visit compared to baseline. No adverse event was recorded during the study period, and on follow-up. CONCLUSIONS: The results of this clinical study suggest that a 90 days treatment with a phyto-ingredient-based Kerascalp hair serum is safe and effective in significantly improving A:T ratio, hair density, hair thickness, and hair strength, while reducing hair shedding. The improvement in the test parameters persists, even 30 days after stopping the usage of the serum.

Efficacy and safety of innovative acne scar serum in Indian patients (ESTEEM India study).

BACKGROUND: Scarring is a common and undesirable outcome of acne vulgaris. There are limited effective topical formulations for acne scar treatment. The investigational product, acne scar serum (HEXILAK® Acne Scar Serum) is latest topical formulation developed for treatment of acne scar with unique ingredients, Kollaren and Exo-T. OBJECTIVE: Evaluate safety and efficacy of latest acne scar serum on the reduction of acne scars in Indian population. MATERIALS AND METHODS: Subjects, diagnosed clinically with acne scars with or without hyperpigmentation, of either gender in the age group of 15 to 45 years were enrolled in the study. The investigational acne scar serum was applied twice daily for 3 months with monthly follow for outcome evaluation. RESULTS: Out of 72 subjects enrolled, 67 completed the study. Most of the subjects, 79.1% showed improvement in acne scar at Day 90. Significant reduction of mean total post-acne hyperpigmentation index (PAHI) was seen at all follow up visits compared with baseline. Significant improvement in mean acne scar depth, mean acne scar volume, and mean L value using 3D imaging were observed at all visits compared with baseline. All side effects reported were mild and overall, it was well tolerated by all subjects. CONCLUSION: We found that there was a significant reduction in acne scar and post-acne pigmentation with new acne scar serum as a monotherapy, this needs further confirmation in larger randomized controlled studies. Therefore, topical acne scar serum with unique ingredients Kollaren and Exo-T can be a safe, effective, and new option in the armamentarium of acne scar management.

Low-dose Oral Minoxidil in the Treatment of Alopecia: Evidence and Experience-based Consensus Statement of Indian Experts.

Alopecia is a highly prevalent condition worldwide including in India. There are different types of alopecia with differing etiology, presentation, and hence treatment. Androgenetic alopecia represents the most common form of hair loss affecting male as well as female population termed as male and female pattern hair loss, respectively. Several treatment options are available for the treatment of alopecia with often unsatisfactory results resulting in psychological distress among such patients. Topical minoxidil is known to be effective in the treatment of alopecia. However, oral minoxidil is not currently approved for the treatment of alopecia. This expert consensus is prepared to provide guidance to the clinicians regarding the use of oral minoxidil in the treatment of alopecia. Extensive literature review was performed to prepare the draft consensus which was then revised based on the suggestions and comments from the experts. The final draft was circulated to the experts for review and approval. This consensus document provides overview of evidence related to oral minoxidil and consensus from the experts for its use in the treatment of minoxidil.

Expert consensus on the management of Androgenetic Alopecia in India.

Androgenetic alopecia (AGA), also known as androgenic or pattern alopecia, is a frequently reported disorder that affects both the sexes, with a higher incidence generally reported in men. AGA has immense psychological effects on the patient, irrespective of the age or stage of baldness. This consensus document has been developed taking into account the opinions of leading experts in the field of dermatology. The objective of this article is to provide the dermatologists with an evidence-based platform for choosing efficacious and safe therapy for patients with AGA. This review articulately summarizes the key opinions of the experts on all aspects of treatment for the effective management of AGA.

Expert consensus on the management of Telogen Effluvium in India.

Alopecia, a frequently reported problem, severely impacts the quality of life of patients and is often associated with loss of confidence and low self-esteem. Several conditions such as telogen effluvium (TE), anagen effluvium, diffuse type of alopecia areata, female pattern hair loss, hair shaft abnormalities, loose anagen hair syndrome, and congenital atrichia or hypotrichosis are associated with hair loss. The actual prevalence rate of TE is not reported since most cases are subclinical in nature. Further, since women get more distressed by hair fall and promptly seek treatment, they tend to be over-represented. However, both genders can suffer from this condition if triggering factors are present. This consensus paper was developed by taking into account opinions of renowned experts in the field and is hoped to serve as an evidence-based platform for selecting efficacious and safe therapy for patients with TE. This review presents a synopsis of the key opinions of experts on all aspects of treatment and effective management of this condition.

Synchronizing Pharmacotherapy in Acne with Review of Clinical Care.

Acne is a chronic inflammatory skin disease that involves the pathogenesis of four major factors, such as androgen-induced increased sebum secretion, altered keratinization, colonization of Propionibacterium acnes, and inflammation. Several acne mono-treatment and combination treatment regimens are available and prescribed in the Indian market, ranging from retinoids, benzoyl peroxide (BPO), anti-infectives, and other miscellaneous agents. Although standard guidelines and recommendations overview the management of mild, moderate, and severe acne, relevance and positioning of each category of pharmacotherapy available in Indian market are still unexplained. The present article discusses the available topical and oral acne therapies and the challenges associated with the overall management of acne in India and suggestions and recommendations by the Indian dermatologists. The experts opined that among topical therapies, the combination therapies are preferred over monotherapy due to associated lower efficacy, poor tolerability, safety issues, adverse effects, and emerging bacterial resistance. Retinoids are preferred in comedonal acne and as maintenance therapy. In case of poor response, combination therapies BPO-retinoid or retinoid-antibacterials in papulopustular acne and retinoid-BPO or BPO-antibacterials in pustular-nodular acne are recommended. Oral agents are generally recommended for severe acne. Low-dose retinoids are economical and have better patient acceptance. Antibiotics should be prescribed till the inflammation is clinically visible. Antiandrogen therapy should be given to women with high androgen levels and are added to regimen to regularize the menstrual cycle. In late-onset hyperandrogenism, oral corticosteroids should be used. The experts recommended that an early initiation of therapy is directly proportional to effective therapeutic outcomes and prevent complications.

Standard Guidelines of Care: Performing Procedures in Patients on or Recently Administered with Isotretinoin.

BACKGROUND: Currently, the standard protocol regarding the performance of procedures on patients receiving or having recently received isotretinoin (13-cis-retinoic acid) states that the procedures should not be performed. The recommendations in standard books and drug insert require discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. These recommendations have been followed for over two decades despite little evidence for the stated increased risk of scarring. OBJECTIVE: The Association of Cutaneous Surgeons (I) constituted a task force to review the evidence and to recommend consensus guidelines regarding the safety of skin procedures, including resurfacing, energy-device treatments, and dermatosurgical procedures in patients with concurrent or recent isotretinoin administration. MATERIALS AND METHODS: Data were extracted from the literature through a PubMed search using the keywords "isotretinoin," "safety," "scarring," "keloids," "hypertrophic scarring," and "pigmentation." The evidence was then labeled and circulated to all members of task force for review. RESULTS: The task force is of the opinion that there is insufficient evidence to support the current protocol of avoiding and delaying treatments in the patient group under consideration and recommends that the current practice should be discontinued. The task force concludes that performing procedures such as laser hair removal, fractional lasers for aging and acne scarring, lasers for pigmented skin lesions, fractional radio-frequency microneedling, superficial and medium-depth peels, microdermabrasion, dermaroller, biopsies, radio-frequency ablation, and superficial excisions is safe in patients with concurrent or recent isotretinoin administration.

Surgical Outcome in Patients Taking Concomitant or Recent Intake of Oral Isotretinoin: A Multicentric Study-ISO-AIMS Study.

BACKGROUND: The current standard recommendation is to avoid surgical interventions in patients taking oral isotretinoin. However, this recommendation has been questioned in several recent publications. AIM: To document the safety of cosmetic and surgical interventions, among patients receiving or recently received oral isotretinoin. MATERIALS AND METHODS: Association of Cutaneous Surgeons, India, in May 2012, initiated this study, at 11 centers in different parts of India. The data of 183 cases were collected monthly, from June 2012 to May 2013. Of these 61 patients had stopped oral isotretinoin before surgery and 122 were concomitantly taking oral isotretinoin during the study period. In these 183 patients, a total of 504 interventions were performed. These included[1] 246 sessions of chemical peels such as glycolic acid, salicylic acid, trichloroacetic acid, and combination peels;[2] 158 sessions of lasers such as ablative fractional laser resurfacing with erbium-doped yttrium aluminum garnet and CO2, conventional full face CO2 laser resurfacing, laser-assisted hair reduction with long-pulsed neodymium-doped yttrium aluminum garnet, diode laser, and LASIK surgery;[3] 27 sessions of cold steel surgeries such as microneedling, skin biopsy, subcision, punch elevation of scars, excision of skin lesion, and wisdom tooth extraction;[4] 1 session of electrosurgery. RESULTS: No significant side effects were noted in most patients. 2 cases of keloid were documented which amounted to 0.4% of side effects in 504 interventions, with a significant P value of 0.000. Reversible transient side effects were erythema in 10 interventions and hyperpigmentation in 15. CONCLUSION: The study showed that performing dermatosurgical and laser procedures in patients receiving or recently received isotretinoin is safe, and the current guidelines of avoiding dermatosurgical and laser interventions in such patients taking isotretinoin need to be revised.

Evidence-based treatment for melasma: expert opinion and a review.

INTRODUCTION: Melasma is one of the most common pigmentary disorders seen by dermatologists and often occurs among women with darker complexion (Fitzpatrick skin type IV-VI). Even though melasma is a widely recognized cause of significant cosmetic disfigurement worldwide and in India, there is a lack of systematic and clinically usable treatment algorithms and guidelines for melasma management. The present article outlines the epidemiology of melasma, reviews the various treatment options along with their mode of action, underscores the diagnostic dilemmas and quantification of illness, and weighs the evidence of currently available therapies. METHODS: A panel of eminent dermatologists was created and their expert opinion was sought to address lacunae in information to arrive at a working algorithm for optimizing outcome in Indian patients. A thorough literature search from recognized medical databases preceded the panel discussions. The discussions and consensus from the panel discussions were drafted and refined as evidence-based treatment for melasma. The deployment of this algorithm is expected to act as a basis for guiding and refining therapy in the future. RESULTS: It is recommended that photoprotection and modified Kligman's formula can be used as a first-line therapy for up to 12 weeks. In most patients, maintenance therapy will be necessary with non-hydroquinone (HQ) products or fixed triple combination intermittently, twice a week or less often. Concomitant camouflage should be offered to the patient at any stage during therapy. Monthly follow-ups are recommended to assess the compliance, tolerance, and efficacy of therapy. CONCLUSION: The key therapy recommended is fluorinated steroid containing 2-4% HQ-based triple combination for first line, with additional selective peels if required in second line. Lasers are a last resort.

A cross-sectional, multicentric clinico-epidemiological study of melasma in India.

BACKGROUND: Melasma is one of the most common pigment disorders seen by a dermatologist and often occurs among women with darker complexion (skin type IV-VI). AIMS: The present study aimed to investigate the epidemiology of melasma in the Indian population and to focus on the regional variability in the demographics, clinical manifestations and factors that precipitate this condition. METHODS: The present multicentric study conducted across four regions in India enrolled patients (>18 years) diagnosed with melasma on Wood's light examination. Patients were examined to identify the distribution of melasma. Various precipitating and etiological factors for melasma were documented. RESULTS: The mean age of the 331 enrolled patients with melasma was 37.2 ± 9.3 years. The prevalence of melasma was higher in females with a female to male ratio of approximately 4:1. The overall population with family history was 31%, highest in the northern region (38.5%) and lowest in the eastern region (18.2%). The two prominent patterns of distribution were centrofacial (42%) and malar (39%). Only 35% of the patients were using sunscreens. Of these, 10% of the patients used sunscreen with SPF >50. The usage of sunscreens was observed to be highest in the north (69%). About 51% of women with multiple pregnancies had a history of melasma when compared with single women (25%) or with no pregnancy (24%). CONCLUSIONS: In conclusion, the result of the study showed that there was a regional variability in the demographics, clinical manifestations and factors that precipitate melasma among patients in India. There was a strong correlation between the family history and prevalence of melasma. Sun exposure is a major precipitating factor in melasma, but only 10% of the patients used sunscreen with SPF >50. Other factors such as concomitant medication, chronicity of disease, multiple pregnancies and use of oral contraceptives might precipitate melasma.