Topical Stabilized Super-Oxidized Hypochlorous Acid for Wound Healing in Hair Restoration Surgery: A Real-Time Usage-Controlled Trial Evaluating Safety, Efficacy, and Tolerability.

OBJECTIVE: Assess the perceived efficacy of stabilized, super-oxidized hypochlorous acid (HOCl) in hair transplant surgical procedures intraoperative and postoperative. BACKGROUND: Stabilized, super-oxidized hypochlorous acid (HOCl) is highly effective against bacterial, fungal, and viral microorganisms. In addition, topical HOCl will increase tissue oxygenation of wound sites to aid in healing. This molecule represents an ideal agent for intraoperative and postoperative use in hair restoration procedures that involve thousands of small wounds. METHODS: 35 patients were enrolled in a multi-site study following repeat or initial hair restoration surgery. Surgeons were provided a 500 mL trigger spray bottle of HOCl spray liquid for use prior to and throughout the surgical procedure. Patients were provided with a ten-day supply of HOCl for postoperative care. Two formulations were utilized, one was applied to the recipient sites while the other was applied to the donor area postoperatively. Patients and surgeons were provided with observational surveys regarding healing and usage of the products. RESULTS: Statistical analysis found 56% had significant reduction in the amount of erythema compared to their current wound healing regimen. More than half of the patients (54%) had significant improvement of pruritus. The compliance rating for this study was 97% among patients. Surgeons were queried on the overall efficacy. There were no incidences of donor or recipient tissue necrosis. CONCLUSION: The evolution of hair restoration surgery has been accompanied by large numbers of grafts being implanted. This change necessitates the requirement for optimum intraoperative and postoperative care. Topical, stabilized hypochlorous spray represents a major advance in wound cleansing and healing and offers the theoretical benefits of reducing tissue necrosis through oxygenation. J Drugs Dermatol. 2023;22(12):1191-1196. doi:10.36849/JDD.7172.

The Progressive Loss Risk Scale for Hair Restoration Surgery.

BACKGROUND: Limited information exists on the long-term risks to individuals undergoing procedures in hair restoration surgery. The short-term risks are well known and similar to other procedures in dermatologic surgery. The long-term risks of hair restoration surgery are seldom discussed between the physician and patient. OBJECTIVE: The author sought to describe a classification system that can be used as a communication tool between physicians and patients to define the long-term risk involved with hair restoration surgery. METHODS: The Progressive Loss (PL) Scale is an attempt at assessing the cosmesis because of future hair loss following a hair transplant procedure. The PL Risk Scale has designated 5 levels, 1 to 5, with each ascending level representing a higher level of risk. The PL Risk Scale can be assigned to an individual at the time of the assessment for hair restoration surgery. RESULTS: Each patient can be assigned a risk level based on how future hair loss may affect the overall cosmetic result of their hair transplant. This risk is dependent on age, and specific for the area to be transplanted. The younger the age of the patient, the higher the risk. The larger the area to be transplanted, the higher the risk. It is not a static scale, because it will be affected by age, donor area, location of transplantation, and other mitigating factors. CONCLUSION: Pattern baldness in men and women is progressive and unrelenting. The dichotomy of hair restoration surgery is that a satisfactory short-term outcome can evolve to disappointing results because of progressive hair loss. The PL Risk Scale can be assigned to every individual undergoing a hair restoration procedure. This scale assignment will convey to the patient their lifetime risk associated with any given surgical hair restoration procedure for that age and the specific area to be restored.

A randomized, double-blind, vehicle-controlled crossover study to determine the anti-pruritic efficacy, safety and local dermal tolerability of a topical formulation (srd174 cream) of the long-acting opiod antagonist nalmefene in subjects with atopic dermatitis.

OBJECTIVE: To investigate the efficacy, safety and tolerability of topical nalmefene (SRD174), a long acting opioid antagonist for the management of pruritus associated with atopic dermatitis (AD). DESIGN: Double-blind, vehicle-controlled, randomized, cross-over trial. SETTING: Eleven dermatology outpatient clinics in the U.S. PATIENTS: Sixty-two out of 136 screened adult subjects with confirmed AD affecting is less than or equal to 20% of body surface area and with moderate-to-severe pruritus. INTERVENTIONS: SRD174 cream or matching vehicle cream applied as required during two 7-day periods separated by a wash-out period. MAIN OUTCOME MEASURE(S): The primary efficacy variable was the period mean of the sum of pruritus intensity difference (SPID) from 0 to 4 hours (SPID0-4) where pruritus was measured on a 0-100 scale Visual Analog Scale (VAS) at seven pre-specified time-points following study drug application. A range of secondary efficacy, safety and tolerance endpoints were included. RESULTS: The LS means for the SPID0-4 (± SD) for SRD174 cream and Vehicle were 210.7 (20.4) and 212.1 (20.2), respectively (Difference = -1.3 (95% CI: -25.9, 23.3). None of the secondary efficacy endpoints tested demonstrated a statistically significant or clinically important difference between the test product and the vehicle. Overall, the SRD174 cream was well tolerated although there was a higher incidence of AEs when subjects took SRD174 cream (22, 36.7 percent of subjects) compared with when they were taking vehicle (14, 23.3 percent of subjects). CONCLUSIONS: SRD174 cream did not demonstrate efficacy in the treatment of pruritus associated with atopic dermatitis raising questions on the role of peripheral opioid receptors as a target for the treatment of pruritus in this population.

Fluorouracil cream 0.5% for actinic keratoses on multiple body sites: an 18-month open-label study.

This prospective 18-month, open-label, multicenter study assessed the long-term safety and efficacy of fluorouracil cream 0.5% in 277 participants with multiple actinic keratoses (AKs) on the face/anterior scalp and other body sites. Two treatment/observation cycles were separated by 12 months. During treatment cycle 1 (TC1), all participants were treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Twelve months later, all participants were assessed for treatment cycle 2 (TC2); participants with face/anterior scalp AKs (N = 98) were re-treated with fluorouracil cream 0.5% for 4 weeks with 4-week follow-up. Only 4 participants (7.4%) experienced a treatment-related adverse event (AE) that was not an application site reaction or eye irritation. No unexpected AEs were reported; most were mild or moderate. After TC1 (week 8), the number of AK lesions was significantly reduced on the face/anterior scalp and all other treated body sites (P < .0001). Clearance rates were 30.5% (hands), 39.8% (face/anterior scalp), and 79.1% (lips). After TC2 (week 60), face/anterior scalp AKs were significantly reduced (P < .0001) and the clearance rate was 33.3%. This study indicates that fluorouracil cream 0.5% with a patented microsponge delivery system was well-tolerated and effective in treating and preventing recurrence of AK lesions up to 18 months after initial treatment.

Efficacy and safety of spinosad and permethrin creme rinses for pediculosis capitis (head lice).

OBJECTIVE: Studies compared spinosad creme rinse and permethrin lice treatment under "actual-use" conditions for pediculosis capitis (head lice). SUBJECTS AND MATERIALS: Two phase-3, multicenter, randomized, evaluator/investigator-blinded studies compared 0.9% spinosad without nit-combing to 1% permethrin with combing (according to product instructions) in 1038 males and females aged > or =6 months. Spinosad-with-combing groups were included for descriptive, noninferential purposes only. Within 391 households, youngest members having > or =3 live lice were designated primary participants. All household members with lice received the same treatment. Participants administered product 1 to 2 times during the 21-day home-use period on the basis of complete lice eradication after a single use or the presence of lice requiring a second treatment. Scalp evaluations were performed at baseline, day 7, and day 14 (and day 21 for participants treated twice). The primary end point was the proportion of lice-free primary participants 14 days after last treatment. RESULTS: A total of 84.6% (study 1) and 86.7% (study 2) of spinosad-treated participants were lice free versus 44.9% and 42.9% permethrin-treated participants (P < .001). Most spinosad-treated participants required 1 application, whereas most permethrin-treated participants required 2 applications. Few adverse events were reported, but those occurring were mild to moderate, including eye irritation (permethrin), ocular hyperemia, and application-site erythema/irritation (both medications). No laboratory measure changed significantly. CONCLUSIONS: Spinosad, which did not require nit combing, was significantly more effective than permethrin in 2 studies reflecting actual-use conditions, and most spinosad-treated participants required only 1 application. Spinosad is a more convenient and effective treatment for pediculosis capitis.

Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis.

BACKGROUND: There is a need for improved medical approaches to the treatment of actinic keratosis. Ingenol mebutate, a diterpene ester extracted and purified from the plant Euphorbia peplus, is being evaluated as a topical therapy for actinic keratosis. OBJECTIVE: Assess the efficacy and safety of ingenol mebutate (formerly PEP005) gel at 3 dosing regimens for the treatment of actinic keratosis. METHODS: Patients with non-facial actinic keratoses applied vehicle gel for 3 days, ingenol mebutate gel, 0.025% for 3 days, or ingenol mebutate gel, 0.05% for 2 or 3 days, with an 8-week follow-up period. RESULTS: All 3 active treatments were significantly more effective than vehicle at clearing actinic keratosis lesions, with a dose response observed. The partial clearance rate (primary efficacy end point) for patients treated with ingenol mebutate gel ranged from 56.0% to 75.4% compared with 21.7% for vehicle gel (P = .0002 to P < .0001 vs vehicle). The complete clearance rate was also significantly higher (P < or = .0006) for patients in the ingenol mebutate gel treatment groups (range: 40.0% to 54.4%) compared with vehicle (11.7%), as was the baseline clearance rate (range: 42.0% to 57.9% for ingenol mebutate gel compared with 13.3% for vehicle, P < .0001 to .0007 vs vehicle). The median percentage reduction in baseline actinic keratosis lesions for patients treated with ingenol mebutate gel ranged from 75% to 100% compared with 0% for vehicle gel (P < .0001 vs vehicle). Active treatment was well tolerated at all dosages. The mechanism of action of this agent is the localized induction of necrosis followed by a transient inflammatory response, and this was manifested in most patients as transient local skin responses consisting primarily of erythema, flaking/scaling, and crusting. There was no evidence of treatment-related scarring. LIMITATIONS: Local skin responses may have suggested active treatment to investigators. CONCLUSIONS: Short-course, field-directed therapy with ingenol mebutate gel for actinic keratoses on non-facial sites seems to be effective with a favorable safety profile and potential benefits over topical agents that require a more prolonged course of treatment.

Fluorouracil cream 0.5% for the treatment of actinic keratoses on the face and anterior scalp: interim results of an 18-month open-label study.

OBJECTIVE: This study further assessed the long-term safety and efficacy of fluorouracil cream 0.5% in patients with multiple actinic keratosis (AK) on the face/anterior scalp and other body sites. DESIGN/SETTING: This 18-month, prospective, open-label, multicenter study comprised two treatment cycles separated by 12 months. Cycle 1 included treatment of AK lesions on the face, anterior scalp, posterior scalp, ears, neck, lips, arms, and/or hands. Once-daily fluorouracil cream 0.5% was applied for four weeks as tolerated, followed by four weeks of follow-up in each treatment cycle. PARTICIPANTS: Adults (N=277) with five or more visible and/or palpable AK lesions on the face/anterior scalp and five or more lesions on the posterior scalp, ears, neck, lips, arms, and/or hands were enrolled. MEASUREMENTS: Main outcome measures included adverse events (AEs) and reduction/clearance of AK lesions on the face/anterior scalp after four weeks of treatment. RESULTS: RESULTS for treatment of AK lesions on the face/anterior scalp for Cycle 1 are reported. All 277 patients were treated during Cycle 1. Besides anticipated application-site reactions (67.9% and 19.1% of patients experiencing mild-to-moderate and severe events, respectively) and eye irritation, overall incidence of treatment-emergent AEs was low. No individual AE appeared in greater than four percent of patients. At the end of Cycle 1, significant reductions were noted in lesion counts on the face/anterior scalp (84.8%; P<0.0001). Clearance rate for lesions on the face and anterior scalp was 39.8 percent at eight weeks. CONCLUSION: RESULTS indicate that fluorouracil cream 0.5% is safe and effective for patients with multiple AK lesions on the face/anterior scalp.

Dutasteride improves male pattern hair loss in a randomized study in identical twins.

OBJECTIVES: This study compared the efficacy of dutasteride vs. placebo in the treatment of male pattern hair loss (androgenetic alopecia) in 17 pairs of identical twin males with androgenetic alopecia over a 1-year period. METHODS: In this randomized, double-blind, placebo-controlled, single-center study, one twin from each identical twin pair received dutasteride 0.5 mg/day for 12 months while the other received placebo for 12 months. Hair growth was evaluated using standardized clinical photographs, hair counts, and patient self-assessment questionnaires. RESULT: Dutasteride significantly improved hair growth at 1-year compared to placebo based on the analysis of the investigator assessment and the patient self-assessment questionnaires. Sixteen of 17 sets of twins completed the study, of which 15 sets correctly predicted the use of dutasteride. Only one set could not determine the active drug from the placebo. CONCLUSION: Through the use of identical twins, this randomized trial provides evidence that dutasteride significantly reduces hair loss progression in men with male pattern hair loss.

The importance of dual 5alpha-reductase inhibition in the treatment of male pattern hair loss: results of a randomized placebo-controlled study of dutasteride versus finasteride.

BACKGROUND: Male pattern hair loss (MPHL) is a potentially reversible condition in which dihydrotestosterone is an important etiologic factor. OBJECTIVE: Our aim was to evaluate the efficacy of the type 1 and 2 5alpha-reductase inhibitor dutasteride in men with MPHL. METHODS: Four hundred sixteen men, 21 to 45 years old, were randomized to receive dutasteride 0.05, 0.1, 0.5 or 2.5 mg, finasteride 5 mg, or placebo daily for 24 weeks. RESULTS: Dutasteride increased target area hair count versus placebo in a dose-dependent fashion and dutasteride 2.5 mg was superior to finasteride at 12 and 24 weeks. Expert panel photographic review and investigator assessment of hair growth confirmed these results. Scalp and serum dihydrotestosterone levels decreased, and testosterone levels increased, in a dose-dependent fashion with dutasteride. LIMITATIONS: The study was limited to 24 weeks. CONCLUSION: Dutasteride increases scalp hair growth in men with MPHL. Type 1 and type 2 5alpha-reductase may be important in the pathogenesis and treatment of MPHL.

Core curriculum for hair restoration surgery, recommended by the International Society of Hair Restoration Surgery (ISHRS).

BACKGROUND: Because hair restoration surgery (HRS) has changed so significantly, the International Society of Hair Restoration Surgery (ISHRS) presents the recently developed Core Curriculum for Hair Restoration Surgery (CCHRS). Physician competence in HRS demands a sound understanding of all of the alternate pathologic causes of hair loss, as well as their risks and treatments. OBJECTIVE: The CCHRS defines the knowledge, didactic information, medical insights, and surgical techniques that are essential to physician competence in the correct diagnoses and treatment of hair loss problems, in a manner consistent with patient safety and sound esthetic results. The ISHRS hopes that all existing surgical and dermatology training programs that teach HRS procedures will find the CCHRS useful in developing their curriculum relative to HRS and that this will facilitate the development of a new standard of training within the profession. METHODS: Developed and reviewed by a committee of experienced hair restoration surgeons. RESULTS: The CCHRS clearly defines the diagnosis and treatment of hair loss as a multidimensional specialty requiring knowledge of several medical disciplines, including genetics, endocrinology, dermatology, and surgery. CONCLUSION: The ISHRS believes that the CCHRS is an important contribution to physician education in HRS and that a clearly defined core curriculum will facilitate achieving contemporary results and higher patient satisfaction.

Safety and efficacy of a new extended-release formulation of minocycline.

The complete safety and efficacy of a new extended-release (ER) minocycline hydrochloride formulation were assessed in an analysis of a phase 2 dose-finding study and 2 phase 3 safety and efficacy studies. The studies were similar in design, subject populations, and shared common dose groups of subjects given ER minocycline 1 mg/kg daily or placebo over 12 weeks. The similar designs were prospective, multicenter, randomized, double-blinded, and placebo-controlled. A total of 1038 subjects with moderate to severe acne were available for the pooled analysis. Independently, each study showed that treatment with ER-minocycline significantly reduced (P < .001) the number of inflammatory lesions and significantly improved (P < .001) their Evaluator's Global Severity Assessment (EGSA) scores (phase 3 studies). Analysis of the pooled population confirmed the results of the individual studies. The percentage of subjects reporting acute vestibular adverse events (AVAEs) was comparable between those receiving the ER-minocycline 1-mg/kg dose and placebo (approximately 10% of subjects in each group) for both the individual studies and the pooled population. It was concluded that a novel ER-minocycline formulation that delivers consistent levels of drug at a 1-mg/kg dose reduces dose-dependent AVAEs while reducing inflammatory lesions and improving the overall appearance of patients with acne vulgaris.

Psychological effect, pathophysiology, and management of androgenetic alopecia in men.

Androgenetic alopecia In men, or male pattern baldness, is recognized increasingly as a physically and psychologically harmful medical condition that can be managed effectively by generalist clinicians. This article discusses the clinical manifestations, epidemiology, physical and psychosocial importance, pathophysiology, diagnosis, and management of androgenetic alopecia in men. Androgenetic alopecia affects at least half of white men by the age of 50 years. Although androgenetic alopecia does not appear to cause direct physical harm, hair loss can result in physical harm because hair protects against sunburn, cold, mechanical injury, and ultraviolet light. Hair loss also can psychologically affect the balding individual and can Influence others' perceptions of him. A progressive condition, male pattern baldness is known to depend on the presence of the androgen dihydrotestosterone and on a genetic predisposition for this condition, but its pathophysiology has not been elucidated fully. Pharmacotherapy, hair transplantation, and cosmetic aids have been used to manage male pattern baldness. Two US Food and Drug Administration-approved hair-loss pharmacotherapies-the potassium channel opener minoxidil and the dihydrotestosterone synthesis inhibitor finasteride--are safe and effective for controlling male pattern baldness with long-term daily use. Regardless of which treatment modality is chosen for male pattern baldness, defining and addressing the patient's expectations regarding therapy are paramount in determining outcome.