Girish S. Munavalli

Successful Treatment of Depressed, Distensible Acne Scars Using Autologous Fibroblasts: A Multi-Site, Prospective, Double Blind, Placebo-Controlled Clinical Trial

Background A previous clinical trial evaluating autologous fibroblasts (human dermal) injections for the treatment of facial contour deformities found significantly greater improvements in wrinkle and acne scar appearance than with placebo treatment. Objective To compare the efficacy and safety of autologous fibroblast treatment of moderate to severe, depressed, distensible facial acne scars with that of vehicle control. Methods This was a randomized multicenter, double‐blind, placebo‐controlled trial in subjects with bilateral moderate to severe acne scarring; subjects served as their own controls. Skin biopsies were obtained from randomized subjects for fibroblast production. Subjects (n = 99) underwent three intradermal injection sessions with 2 mL of autologous fibroblast suspension (10–20 million cells/mL) on one cheek and vehicle control (cell culture medium) on the other at 14‐day intervals. Efficacy was based on the blinded subjects, evaluators, and independent photographic viewers (IPR) assessment of acne scarring 1 to 4 months after the last treatment. Results Autologous fibroblast treatment was associated with significantly greater treatment success than vehicle control for the subject (43% vs 18%), evaluator (59% vs 42%), and IPR assessments. Autologous fibroblast injections were well tolerated, without permanent adverse effects. Conclusions Autologous fibroblast injections safely and effectively improved the appearance of depressed distensible acne scars.

A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles.

BACKGROUND Changes associated with aging are partly due to loss of collagen and elastin. Treatment with autologous fibroblasts grown in culture (azficel‐T) can help correct the appearance of aging by replacing lost dermal constituents. OBJECTIVE To demonstrate the safety and effectiveness of autologous fibroblasts in the treatment of nasolabial fold (NLF) wrinkles. METHODS AND MATERIALS Adults with moderate to very severe NLF wrinkles were randomized to receive three treatments with autologous fibroblasts or placebo at 5‐week intervals. Blinded evaluators and subjects assessed efficacy using a validated wrinkle assessment scale. RESULTS Three hundred seventy‐two subjects were enrolled and underwent treatment. Seventy‐eight percent of subjects treated with autologous fibroblast therapy and 48% of subjects treated with placebo achieved at least a 1‐point improvement on the subject assessment at 6 months (p < 0.001), and 64% of subjects treated with autologous fibroblast therapy and 36% of those treated with placebo showed at least a 1–point improvement evaluators assessment (p < 0.001). Adverse events were generally mild, and the treatment was well tolerated. CONCLUSION Autologous fibroblast therapy is safe and effective for the treatment of NLF wrinkles. The availability of autologous cell therapy marks the beginning of a new phase in aesthetic therapy.

Evidence for Laser-and Light-Based Treatment of Acne Vulgaris

Acne is a very prevalent skin disorder, affecting more than 85% of adolescents and often continuing into adulthood. Active acne and its sequelae, especially permanent scarring, may cause longstanding psychological or emotional harm in patients. Novel and promising treatments with laser/light devices (such as blue light, red light, pulsed dye laser, infrared lasers, light-emitting diodes, and pulsed light) have been reported to have varying degrees of efficacy for treatment. The authors compiled a summary of evidence-based literature on laser/light treatment for acne to assist clinicians to more appropriately identify treatment options, should they choose to supplement current medical antiacne therapies.

Photodynamic Therapy: A Clinical Consensus Guide.

BACKGROUND The American Society of Dermatologic Surgery (ASDS) periodically develops consensus documents for its members concerning various aspects of dermatologic surgery. Advances in photodynamic therapy (PDT) have been many and PDT use has been established in a variety of skin conditions. OBJECTIVE The ASDS board of directors proposed a committee of experts in the field to develop consensus documents on different treatments. An expert panel reviewed the literature on PDT and discussed the findings. The consensus was reached with evidence-based recommendations on different clinical applications for PDT. PATIENTS AND METHODS This consensus document includes discussions regarding PDT, including different photosensitizers and various light source activators, historical perspective, mechanism of action, various therapeutic indications and expected outcomes, pre- and post-care, and management of adverse outcomes. RESULTS Photodynamic therapy is highly effective for pre-cancerous lesions, superficial nonmelanoma skin cancers, inflammatory acne vulgaris and other conditions. New protocols including laser mediated PDT significantly improve results for several indications. CONCLUSION The ASDS consensus document on PDT will be helpful for educating members on safe and effective PDT for a variety of indications.

Cryolipolysis for Targeted Fat Reduction and Improved Appearance of the Enlarged Male Breast.

BACKGROUND Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat. Standard treatment is surgical excision under general anesthesia, liposuction, or a combination of both. OBJECTIVE The safety and efficacy of cryolipolysis was investigated for nonsurgical treatment of pseudogynecomastia. METHODS AND MATERIALS Enrollment consisted of 21 males with pseudogynecomastia. Subjects received a first treatment consisting of a 60-minute cryolipolysis cycle, followed by a two-minute massage, and a second 60-minute cycle with 50% treatment area overlap. At 60 days of follow-up, subjects received a second 60-minute treatment. Safety was evaluated by monitoring side effects and adverse events. Efficacy was assessed by ultrasound, clinical photographs, and subject surveys. RESULTS Surveys revealed that 95% of subjects reported improved visual appearance and 89% reported reduced embarrassment associated with pseudogynecomastia. Ultrasound showed mean fat layer reduction of 1.6 ± 1.2 mm. Blinded reviewers correctly identified 82% of baseline photographs. Side effects included mild discomfort during treatment and transient paresthesia and tenderness. One case of paradoxical hyperplasia (PH) occurred but likelihood of PH in the male breast is not believed to be greater than in any other treatment area. CONCLUSION This study demonstrated feasibility of cryolipolysis for safe, effective, and well-tolerated nonsurgical treatment of pseudogynecomastia.

Isotretinoin and Timing of Procedural Interventions: A Systematic Review With Consensus Recommendations.

Importance The notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contributes to abnormal scarring or delayed wound healing is widely taught and practiced; however, it is based on 3 small case series from the mid-1980s. Objective To evaluate the body of literature to provide evidence-based recommendations regarding the safety of procedural interventions performed either concurrently with, or immediately following the cessation of systemic isotretinoin therapy. Evidence Review A panel of national experts in pediatric dermatology, procedural/cosmetic dermatology, plastic surgery, scars, wound healing, acne, and isotretinoin was convened. A systematic PubMed review of English-language articles published from 1982 to 2017 was performed using the following search terms: isotretinoin, 13-cis-retinoic acid, Accutane, retinoids, acitretin, surgery, surgical, laser, ablative laser, nonablative laser, laser hair removal, chemical peel, dermabrasion, wound healing, safety, scarring, hypertrophic scar, and keloid. Evidence was graded, and expert consensus was obtained. Findings Thirty-two relevant publications reported 1485 procedures. There was insufficient evidence to support delaying manual dermabrasion, superficial chemical peels, cutaneous surgery, laser hair removal, and fractional ablative and nonablative laser procedures for patients currently receiving or having recently completed isotretinoin therapy. Based on the available literature, mechanical dermabrasion and fully ablative laser are not recommended in the setting of systemic isotretinoin treatment. Conclusions and Relevance Physicians and patients may have an evidence-based discussion regarding the known risk of cutaneous surgical procedures in the setting of systemic isotretinoin therapy. For some patients and some conditions, an informed decision may lead to earlier and potentially more effective interventions.

A new multi-modal fractional ablative CO2 laser for wrinkle reduction and skin resurfacing

Abstract Background: The concept of fractional delivery modality of the energy with both ablative and non-ablative devices is now well known and accepted as an effective method to attain significant aesthetic improvements on facial aging skin. A new, multi-modal, fractional, ablative CO2 laser that can create, using same scanner/handpiece, deep columns in addition to superficial ablation has been recently proposed and therefore investigated. Method: Twenty-four patients were enrolled in this evaluation. Each of them received one multi-modal, fractional ablative treatment. Patients were clinically and photographically evaluated at baseline and 6 months after the procedure. The degree of photoaging and the efficacy of treatment were evaluated using a VAS five-point scale of some skin features. A 3D images comparison was furthermore performed to objectify the improvements. Results: For all of the analysed skin features of photodamage a significant, statistical improvement was obtained. The data collected with the 3D system demonstrated an average improvement of 42% of the wrinkles and an average improvement of the melanin variation of 40.1%. Conclusions: The multi-modal approach with a single handpiece allows obtaining good outcomes with a very low incidence of adverse effects and a short downtime.

Low-fluence 585 nm Q-switched Nd:YAG laser: a novel laser treatment for post-acne erythema.

Persistent post‐acne erythema is one of the most common aesthetic sequelae to arise after active acne resolves. The treatment remains challenging due to lack of effective laser modalities.

Fractional 1,550nm Ytterbium/Erbium fiber laser in the treatment of lichen amyloidosis: Clinical and histological study

Lichen amyloidosis is characterized by amyloid deposition in the papillary dermis, presenting clinically with intensely pruritic hyperkeratotic papules. Various treatment modalities have been used but the results are generally unsatisfactory. Several studies show that non‐ablative fractional lasers can be used to treat depositional diseases due to their capability of inducing transepidermal elimination of the dermal content. To investigate the efficacy and safety of a non‐ablative fractional 1,550 nm Yttrium/Erbium fiber laser for the treatment of lichen amyloidosis.

Fractional high intensity focused radiofrequency in the treatment of mild to Moderate laxity of the lower face and neck: A pilot study

The aging process is commonly associated with skin laxity in the lower face and neck. Conventional surgery can correct this at least to some extent, but is invasive. Fractional high‐intensity focused radiofrequency delivered to the dermis with insulated microneedles has recently attracted attention in facial rejuvenation. The present pilot study was designed to assess the efficacy of HiFR for skin laxity of the lower face and neck.