Effect of platelet counts and activator in platelet-rich plasma on the treatment of androgenetic alopecia, split-head comparison: A randomised, double-blind study.

Background Androgenetic alopecia is a common, chronic, non-scarring alopecia. It is characterised by stepwise miniaturisation of the hair follicles, due to alteration in the hair cycle dynamics, leading to the transformation of terminal hair follicles into a vellus ones. Oral finasteride and topical minoxidil are the only approved drugs for treating this condition. Due to a limited number of effective therapies for androgenetic alopecia, platelet-rich plasma may be an effective alternative treatment. Aims To study the effect of activator in platelet-rich plasma and baseline platelet count in platelet-rich plasma on the treatment of androgenetic alopecia. Methods A randomised, double-blind split-head comparative study. The sample size was calculated and randomisation was done. Patients with androgenetic alopecia were allocated into two groups; in the first group, autologous activated platelet-rich plasma was injected in the right half of the affected scalp and autologous non-activated platelet-rich plasma was injected in the left half of the affected scalp and vice versa in the second group. Patients were also categorised on the basis of platelet counts in their platelet-rich plasma in three groups; group A (6-8 lakh/mm3), group B (8.1-10 lakh/mm3) and group C (>10 lakh/mm3). Interventions were done monthly for three months and followed up for the next three months. Effects of interventions were assessed by hair density, hair thickness, patient self-assessment and clinical photography. Results A total of 80 patients were included in the study. Activated platelet-rich plasma produced significant improvement of hair density after four months and hair thickness at 6 months. An increase in platelet count led to a significant increase in hair density and hair thickness after three and four months respectively and a highly significant increase in both parameters at the end of the study. Limitations Long-term follow-up of cases was not done and no measurement of vellus hair count was done. Conclusion There is a significant effect of activator and platelet count of the platelet-rich plasma on hair density as well as hair thickness.

Early use of faecal microbiota transplantation for C. difficile infection.

Overview of: Baunwall SMD, Andreasen SE, Hansen MM, et al Faecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol 2022;7:1083-91.

Effectiveness and safety of 0.5% timolol solution in the treatment of pyogenic granuloma: A randomized, double-blind and placebo-controlled study.

Introduction Pyogenic granulomas are benign vascular lesions of the skin and mucosa which are often a source of concern because of their recurrent bleeding even with minimal trauma. Current treatment for pyogenic granuloma is ablative; no medical therapy is standardized to date. Timolol, due to its vasoconstrictive effect, vascular growth factor inhibition and apoptosis promotion properties, is a potential therapeutic option. Objectives: To assess the effectiveness and safety of topical timolol in the treatment of pyogenic granulomas. Methods A two-centre, double-blind and placebo-controlled trial (Registration CTRI/2019/04/018581) was conducted. Patients of either sex were recruited with pyogenic granuloma lesions of less than eight weeks duration. Topical treatment with 0.5% timolol or matching glycerin placebo was continued for six weeks. Changes in color, size, bleeding tendency, physicians' and patients' global assessments and adverse events were assessed. Results Forty subjects were randomized between the two groups which were comparable in age, sex, duration of illness and baseline lesion size.Significant improvement was noted with timolol, with color change from first follow-up onwards and lesion size reduction from second follow-up onward. Patients' assessment of bleeding tendency also showed imrovement from the second visit onward. Between-group comparison showed significant difference with respect to percentage reduction in size (timolol 40.9%, placebo 3.4%; P = 0.002). Rescue treatment (electrosurgery) was required in five patients on placebo and in one in the timolol group (P = 0.182). Complete resolution occurred in 2 (10%) patients with timolol and in no patients on placebo (P = 0.231). Limitations: We observed effects of treatment for only six weeks. Conclusion Topical timolol may be a treatment option for early pyogenic granulomas but complete resolution is unlikely in six weeks. Studies of longer duration are required to assess resolution and recurrence rates.

Optimal peripheral nerve block after minimally invasive colon surgery - a study protocol for a randomised trial.

Introduction Transversus abdominis plane (TAP) blocks are used for post-operative pain management, but their efficacy remains unclear. We aim to investigate the effect of two TAP block methods in minimally invasive colon surgery. Methods This will be a double-blind, randomised and controlled multicentre trial including 360 adults who are planned for elective minimally invasive colon surgery with curative intent for colon neoplasia. The participants are randomised to one of three arms: active ultrasound-guided TAP (US-TAP) and placebo laparoscopic assisted TAP (L-TAP), placebo US-TAP and active L-TAP, or placebo US-TAP and placebo L-TAP. The primary outcome is morphine dose equivalents administered during the first 24 hours after surgery. Secondary outcomes are pain on the first post-operative day, length of stay, post-operative nausea and vomiting, and quality of recovery measured using the Quality of Recovery 15 questionnaire. Statistical analysis will determine any superiority of US-TAP and L-TAP versus placebo, and any non-inferiority of L-TAP compared with US-TAP. The latter will only be tested if superiority to placebo is shown. Primary and secondary outcomes will be analysed as intention-to-treat regarding superiority and as intention-to-treat and per protocol regarding non-inferiority. Conclusion This will be the first ever blinded multicentre trial comparing L-TAP, US-TAP and placebo in daily clinical practice. The study has the potential to determine the role of the TAP in minimally invasive colon surgery. Funding A and JC Tvergaards Fond, Helen Rudes Fond, Fru Olga Bryde Nielsens Fond, Aage og Johanne Louis-Hansen Fond, Medicine and Treatment Research Fund of the Danish Regions and a Research Grant from Copenhagen University Hospital - North Zealand Hospital. Trial registration ClinicalTrials.gov: NCT04311099.

BCG re-vaccination in Malawi: 30-year follow-up of a large, randomised, double-blind, placebo-controlled trial.

BACKGROUND: A large, double-blind, randomised, placebo-controlled trial of repeat BCG found 49% efficacy against leprosy but no protection against tuberculosis after 6-9 years' follow-up in 1995. We report here additional follow-up, which resulted in greatly increased tuberculosis case numbers, and allowed subgroup analysis. METHODS: Nearly 47 000 individuals of all ages living in northern Malawi with a BCG vaccine scar were randomly assigned (1:1) between 1986 and 1989 to receive a second BCG or placebo. The investigators and project staff remained masked to all interventions. Enhanced passive surveillance ensured ascertainment of tuberculosis and leprosy to the end of 2018. Tuberculosis case definitions included rigorous microbiological or histological confirmation. Prespecified subgroup analyses were by tuberculosis type, age at vaccination, time since vaccination, previous tuberculin reactivity, HIV status and Mycobacterium tuberculosis lineage. The original trial is registered with ISRCTN registry, ISRCTN11311670. FINDINGS: In follow-up until Dec 31, 2018, 824 participants had developed tuberculosis, including 786 with pulmonary disease, of whom 383 (63%) of 607 with known HIV status were HIV positive. There was no effect of a second BCG overall (odds ratio [OR] 0·92; 95% CI 0·80-1·05), or for pulmonary (0·93; 0·81-1·07), or lymph node tuberculosis (0·60; 0·31-1·17). The OR was lower for those with known HIV-negative tuberculosis (0·77; 0·59-1·00), for those vaccinated as children (aged <5 years, 0·74; 0·41-1·35; aged 5-14 years, 0·77; 0·60-0·99), and for cases arising at least 20 years after vaccination (0·79; 0·63-1·01). There were no differences by tuberculin status at vaccination, or lineage. There was no evidence of protection against leprosy beyond 10 years after vaccination (although there have been only nine diagnostically certain cases since 1995). INTERPRETATION: There was no evidence that repeat BCG vaccination provides appreciable protection against overall tuberculosis in this rural African population with a high prevalence of HIV. Subgroup effects should not be overinterpreted given the multiple analyses done. However, the evidence for modest protection against HIV-negative tuberculosis, and for a delayed benefit in those vaccinated as children, is consistent with other observations in the literature. FUNDING: LEPRA, Wellcome Trust, Bill & Melinda Gates Foundation.

A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance.

BACKGROUND: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses. AIMS AND OBJECTIVES: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo. METHODS: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases. RESULTS: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline. LIMITATIONS: Small sample size and a short follow-up period of our study were major limitations. CONCLUSION: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone.

The effect of BCG revaccination on all-cause mortality beyond infancy: 30-year follow-up of a population-based, double-blind, randomised placebo-controlled trial in Malawi.

BACKGROUND: Trials of BCG vaccination to prevent or reduce severity of COVID-19 are taking place in adults, some of whom have been previously vaccinated, but evidence of the beneficial, non-specific effects of BCG come largely from data on mortality in infants and young children, and from in-vitro and animal studies, after a first BCG vaccination. We assess all-cause mortality following a large BCG revaccination trial in Malawi. METHODS: The Karonga Prevention trial was a population-based, double-blind, randomised controlled in Karonga District, northern Malawi, that enrolled participants between January, 1986, and November, 1989. The trial compared BCG (Glaxo-strain) revaccination versus placebo to prevent tuberculosis and leprosy. 46 889 individuals aged 3 months to 75 years were randomly assigned to receive BCG revaccination (n=23 528) or placebo (n=23 361). Here we report mortality since vaccination as recorded during active follow-up in northern areas of the district in 1991-94, and in a demographic surveillance follow-up in the southern area in 2002-18. 7389 individuals who received BCG (n=3746) or placebo (n=3643) lived in the northern follow-up areas, and 5616 individuals who received BCG (n=2798) or placebo (n=2818) lived in the southern area. Year of death or leaving the area were recorded for those not found. We used survival analysis to estimate all-cause mortality. FINDINGS: Follow-up information was available for 3709 (99·0%) BCG recipients and 3612 (99·1%) placebo recipients in the northern areas, and 2449 (87·5%) BCG recipients and 2413 (85·6%) placebo recipients in the southern area. There was no difference in mortality between the BCG and placebo groups in either area, overall or by age group or sex. In the northern area, there were 129 deaths per 19 694 person-years at risk in the BCG group (6·6 deaths per 1000 person-years at risk [95% CI 5·5-7·8]) versus 133 deaths per 19 111 person-years at risk in the placebo group (7·0 deaths per 1000 person-years at risk [95% CI 5·9-8·2]; HR 0·94 [95% CI 0·74-1·20]; p=0·62). In the southern area, there were 241 deaths per 38 399 person-years at risk in the BCG group (6·3 deaths per 1000 person-years at risk [95% CI 5·5-7·1]) versus 230 deaths per 38 676 person-years at risk in the placebo group (5·9 deaths per 1000 person-years at risk [95% CI 5·2-6·8]; HR 1·06 [95% CI 0·88-1·27]; p=0·54). INTERPRETATION: We found little evidence of any beneficial effect of BCG revaccination on all-cause mortality. The high proportion of deaths attributable to non-infectious causes beyond infancy, and the long time interval since BCG for most deaths, might obscure any benefits. FUNDING: British Leprosy Relief Association (LEPRA); Wellcome Trust.

Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial.

BACKGROUND: Management of moderate-to-severe post-operative pain after elective caesarean section (ECS) is internationally primarily based on either epidural catheters or opioids. However, both techniques are associated with some undesirable adverse events. Bilateral transmuscular quadratus lumborum (TQL) block has proven to reduce opioid consumption significantly in the first 24 post-operative hours following ECS and prolong time to first opioid (TFO) (Hansen CKD, Steingrimsdottir M, Laier GE, et al. Reg Anesth Pain Med. 2019; 10.1136/rapm-2019-100540). We present a randomised controlled trial aiming to investigate whether continuous analgesia via bilateral TQL catheters can prolong TFO after ECS. METHODS: This study is a double-blind, randomised, placebo-controlled trial. Patients should be 18 years or older and scheduled for ECS under spinal anaesthesia to be included. Main exclusion criteria are inability to cooperate, excessive daily intake of opioids and difficult ultrasound visualisation of muscular and fascial structures. Participants are randomised to receive ultrasound-guided injection of either 30 mL ropivacaine 0.2% bilaterally and an elastomeric pump containing 0.2% ropivacaine, or 30 mL saline bilaterally and an elastomeric pump containing saline, 2 hours after catheter placement. The primary endpoint is TFO. Secondary outcomes include pain intensity on a numeric rating scale (NRS), accumulated morphine consumption during 24 hours, displacement frequency of catheters and morphine-related adverse events. RECRUITMENT PERIOD: Four patients were included from September 2018 to November 2018. Inclusion was resumed in June 2019 and will continue until 24 patients with useful data have been included in the trial. Expected inclusion period is 10-14 months. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03663478. EudraCT: 2017-003625-15.

Comparison of efficacy of platelet-rich plasma therapy with or without topical 5% minoxidil in male-type baldness: A randomized, double-blind placebo control trial.

BACKGROUND: Male-type baldness is a common chronic hair loss disorder among males. Male type baldness is characterized by stepwise miniaturization of the hair follicle, due to alteration in the hair cycle dynamics, leading to transformation of the terminal hair follicle into a vellus one. Platelet-rich plasma (PRP) seems to be a new technique which may improve hair regrowth. We planned a randomized, double-blinded placebo control trial to see the efficacy of PRP with and without topical minoxidil and to compare with placebo and standard treatment. MATERIALS AND METHODS: The study design was a randomized, double-blind placebo control trial. The sample size was calculated, and randomization was done. Patients with male type baldness were allocated into four groups; first group topical minoxidil only, the second group PRP with minoxidil, the third group normal saline (NS), and fourth group PRP only. Interventions were done monthly for 3 months and patients were followed up for the next 2 months. Effects of interventions were assessed by hair density, patient self-assessment, and clinical photography. RESULTS: A total of 80 patients were included. The maximum improvement was found in PRP with minoxidil group. Increase in hair density (in descending order) was PRP with minoxidil group, PRP-alone group, minoxidil-alone group, while a decrease in hair density was found in NS group, after 5 months. The maximum patient satisfaction was found in PRP with minoxidil group followed by (in descending order), PRP-alone group, minoxidil-alone group, and NS group. LIMITATION: Long-term follow up of patients was not done. Hair counts and hair thickness estimation were not estimated. CONCLUSION: In our study, we found PRP with topical minoxidil is more effective than PRP alone and topical minoxidil alone.

A double-blind, randomized controlled trial to compare the effectiveness and safety of purified protein derivative of tuberculin antigen with Mycobacterium w vaccine in the treatment of multiple viral warts.

BACKGROUND: Present day therapeutic modalities for viral warts are mostly ablative in nature, limited by high recurrence rates and are unsuitable for numerous lesions. Immunotherapy has the potential to overcome these limitations. AIMS: This study aimed at comparing efficacy and safety of and quality of life changes with intradermal purified protein derivative (PPD) of tuberculin antigen and Mycobacterium w (Mw) vaccine in immunotherapy of warts. METHODS: Patients with multiple (≥5) warts were randomized (1:1) into two groups (PPDand, Mw vaccine groups). Fortnightly, 0.1 ml of either medicine was injected intradermally over the deltoidregion till complete resolution or a maximum of six doses. Patients were followed-up for another 3 months for recurrence. RESULTS: Sixty-four participants received either PPD or Mw vaccine. The number of warts were comparable at baseline (P = 0.089, Mann-Whitney test), and reduced significantly with treatment in both groups (P < 0.001, Friedman's ANOVA), as seen from the fourth follow-up onwards with Mw and fifth follow-up onwards with PPD (P < 0.05, Post hoc Dunn's test). Intergroup comparison showed significantly more (P < 0.05, Mann-Whitney test) reduction with Mw than PPD at the sixth and seventh follow-up. The size of warts also reduced significantly (P < 0.001) in both groups from the third follow-up onwards. Complete remission was more (P = 0.539, Fischer's exact test) in the Mw group (68.8%) than the PPD group (50%); and was significantly higher (P = 0.049, Mann-Whitney test) in patients having shorter duration of warts. Adverse events were significantly more (P < 0.001) with Mw including ulceration (50%), discharge (15.6%), pain-swelling-induration and scar at the injection site (97% each), whereas some of those receiving PPD noted erythema and scaling at the injection site (18.8%), and post-inflammatory hyperpigmentation (12.5%). No recurrence was seen till the end of the study. LIMITATION: Unicentric trial. CONCLUSION: Intradermal injection of Mw vaccine was more effective but had a higher incidence of adverse effects compared to PPD of tuberculin antigen in patients with warts.

The Effects of Multi-Day vs. Single Pre-exercise Nitrate Supplement Dosing on Simulated Cycling Time Trial Performance and Skeletal Muscle Oxygenation.

Jo, E, Fischer, M, Auslander, AT, Beigarten, A, Daggy, B, Hansen, K, Kessler, L, Osmond, A, Wang, H, and Wes, R. The effects of multiday vs. single pre-exercise nitrate supplement dosing on simulated cycling time trial performance and skeletal muscle oxygenation. J Strength Cond Res 33(1): 217-224, 2019-A transient augmentation in the metabolic efficiency of skeletal muscle is the purported basis for dietary nitrate supplementation amongst competitive and recreational athletes alike. Previous studies support the ergogenic effects of nitrate supplementation, as findings indicated improved microvascular blood flow, exercise economy, and performance with relatively short-term supplementation. As with most ergogenic aids, the optimum duration of supplementation before performance or competition, i.e., loading phase, is a critical determinant for efficacy. Therefore, the purpose of this study was to investigate the effects of long-term vs. single dosing nitrate supplementation on skeletal muscle oxygenation and cycling performance. In a randomized, placebo controlled, double blind, parallel design study, healthy, recreationally active men (n = 15) and women (n = 14) subjects (age = 18-29 years) completed an 8 km (5 mi) simulated cycling time trial before and after a 14-day supplementation period with either a nitrate supplement (Multi-Day Dosing Group) (n = 14) or placebo (Single Pre-Exercise Dosing Group; SD) (n = 15). Both groups consumed a single dose of the nitrate supplement 2 hours before the post-treatment time trial. In addition, skeletal muscle oxygenation was measured via near-infrared spectroscopy during each time trial. Multiday nitrate supplementation significantly decreased time to completion (p = 0.01) and increased average power (p = 0.04) and speed (p = 0.02) from pre-to post-treatment, while a single dosing produced no significant changes to these measures. There were no significant differences over time and across treatments for any other measures including muscle oxygenation variables. Overall, long-term nitrate supplementation appears to have an advantage over a single pre-exercise dosing on cycling performance and metabolic efficiency as indicated by an increase in power output with no change in oxygenation.

A randomized, double-blind trial of amorolfine 0.25% cream and sertaconazole 2% cream in limited dermatophytosis.

BACKGROUND: Dermatophytosis is becoming increasingly unresponsive to conventional antifungals. Newer topical antifungals may be more effective in these patients. AIMS: To evaluate and compare the efficacy and safety of amorolfine 0.25% cream and sertaconazole 2% cream in limited tinea cruris/corporis. METHODS: A single-center, randomized (1:1), double-blind, parallel group, active-controlled trial (CTRI/2014/12/005246) was performed. Sixty-six untreated adults with acutely symptomatic tinea cruris/corporis were included in the study. All patients had limited cutaneous involvement and were KOH mount positive. Group A received amorolfine 0.25% cream, and group B received sertaconazole 2% cream twice daily application to the lesions for 4 weeks. After the baseline visit, four follow-up visits were carried out. The outcome measures for effectiveness were clinical and mycological cure. Safety parameters studied were treatment-emergent adverse events and changes in routine laboratory parameters. RESULTS: Both sertaconazole and amorolfine significantly reduced symptoms (P < 0.001) in both groups. However, improvement in symptoms (pruritus, burning sensation, erythema, scaling and crusting) was significantly greater in the sertaconazole group at every follow-up visit. Sertaconazole cream was also more effective than amorolfine cream in reducing the number of lesions (P = 0.002 at 12 weeks) and improving the Dermatology Life Quality Index (P < 0.001) at all the follow-up visits. Adverse events were similar in the two groups (P = 0.117). Fungal cultures became negative in 92.3% of the sertaconazole group as compared to 80% in the amorolfine group (P = 0.010). LIMITATIONS: Antifungal susceptibility testing could not be done. CONCLUSION: Sertaconazole 2% is superior to amorolfine 0.25%, both in terms of effectiveness and tolerability. Improvement can be appreciated from second week onwards.

Evaluating the safety, tolerability, pharmacokinetics and efficacy of clofazimine in cryptosporidiosis (CRYPTOFAZ): study protocol for a randomized controlled trial.

BACKGROUND: Cryptosporidium infection and diarrhea (cryptosporidiosis) is a life-threatening infection in persons with HIV and also in children of 6-18 months of age in the developing world. To date, only nitazoxanide is licensed for treatment of cryptosporidiosis, and only in persons after the first year of life and with healthy immune systems. Clofazimine (CFZ: Lamprene®), an established drug that has been used for leprosy for more than 50 years, recently has been described as effective against Cryptosporidium in vitro and in mouse infections. The efficacy and pharmacokinetics of CFZ in vivo, in HIV-infected patients with cryptosporidial diarrhea are not known. METHODS: CRYPTOFAZ includes a randomized, double-blind, placebo-controlled study of the safety, tolerability and Cryptosporidium inhibitory activity of orally administered CFZ in subjects with HIV infection and chronic diarrhea with Cryptosporidium. An additional open label aspect of the study will compare the pharmacokinetics (PK) of orally administered CFZ in HIV-infected individuals with and without Cryptosporidium-associated diarrhea. The study will recruit a total of 66 subjects. Study participants will be given either CFZ or a placebo for 5 days while in hospital and will be followed up after discharge. Cryptosporidium will be diagnosed by quantitative PCR as the definitive test and by stool ELISA, which will also be used to quantify the shedding of Cryptosporidium in stool. PK will be studied on plasma and stool samples. Primary endpoints include reduction in the number of Cryptosporidium shed in stools over a 5-day period and compared to placebo recipients and the PK of CFZ in plasma assessed by area under the curve, peak plasma concentration, and half-life (T ½) determined after the last dose. DISCUSSION: This study provides an opportunity to explore a possible treatment option for HIV-infected patients with cryptosporidial diarrhea, who, as of now in Malawi and most of sub-Saharan Africa, do not have a definitive treatment apart from supportive care. The strength of this study lies in it being a randomized, double-blind, placebo-controlled trial. If shown to be effective and safe, the findings will also lay a foundation for a future study of the use of CFZ in children 6-18 months of age. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03341767 . Registered on 14 November 2017.

The effectiveness of adding low-level light therapy to minoxidil 5% solution in the treatment of patients with androgenetic alopecia.

BACKGROUND: Androgenetic alopecia is the commonest type of alopecia affecting over half of men and women. Low-level light therapy is a new technique for stimulating hair growth in both genders. AIMS: To overcome the shortcomings of previous epidemiological studies and a lack of controlled clinical trials on the subject, this study compared the effectiveness of adding low-level light therapy to minoxidil topical solution in the treatment of androgenetic alopecia in patients presenting to two skin clinics in Isfahan, Iran during 2014-2015. MATERIALS AND METHODS: This clinical trial included 50 patients aged 17-45 presenting to Khorshid and Alzahra educational centers and skin diseases research center for androgenetic alopecia during 2014-2015. The patients were randomly divided into a control and a case group. The case group received topical minoxidil 5% solution plus low-level light therapy twice per day. The control group was given the same topical solution and a laser comb system that was turned off to act as a placebo. Changes in patients' hair density and diameter and its overall regrowth as well as their satisfaction with the treatment were assessed at months 0 (baseline), 3, 6, 9 and 12. RESULTS: The percentage of recovery from androgenetic alopecia and the patients' satisfaction with their treatment were significantly higher in the case group compared to the control group. The patients' mean hair density and diameter were found to be higher in the case group after the intervention compared to the control group. LIMITATIONS: The study limitations included patient compliance, small sample size, patient insight due to novelty of the method and clinical judgement. CONCLUSION: As a new method of treatment, low-level light therapy can help improve the percentage of recovery from androgenetic alopecia and increase patients' satisfaction with their treatment.

18F-fluorodeoxyglucose positron emission tomography-based evaluation of systemic and vascular inflammation and assessment of the effect of systemic treatment on inflammation in patients with moderate-to-severe psoriasis: A randomized placebo-controlled pilot study.

BACKGROUND: Psoriasis is a systemic inflammatory disorder associated with an increased risk of cardiovascular disease. OBJECTIVE: To evaluate the utility of [[18]F]-fluorodeoxyglucose positron emission tomography/computed tomography in identifying vascular and systemic inflammation in psoriasis patients with moderate-to-severe disease and to analyze its usefulness in assessing the effect of systemic treatment. METHODS: This was a randomized, double-blind pilot study conducted in a tertiary care center. Baseline standardized uptake value score was estimated by18F-fluorodeoxyglucose positron emission tomography/computed tomography in patients with moderate-to-severe psoriasis and compared with historical controls. Patients were then randomized using computer-generated randomization list into methotrexate or placebo (with or without pioglitazone) groups.18F-fluorodeoxyglucose positron emission tomography/computed tomography was repeated at 12 weeks and composite standardized uptake value score determined. The correlation between Psoriasis Activity and Severity Index and SUVmax was assessed. RESULTS: A total of 16 patients were randomized to different treatment groups. Significant increase in mean SUVmax was observed in the ascending aorta in psoriasis patients as compared to historical controls (2.03 ± 0.53 vs 1.51 ± 0.36, P < 0.03). There was no difference in composite standardized uptake value score after 12 weeks of treatment in any of the treatment groups (P = 0.82), although an improvement in Psoriasis Activity and Severity Index score in the methotrexate arm was observed. No correlation was found between mean SUVmax and Psoriasis Activity and Severity Index scores in various aortic segments (r = 0.3-0.7). LIMITATIONS: Small sample size, short follow-up, historical controls, exclusion of patients with comorbid conditions and lack of surrogate markers of systemic inflammation. CONCLUSION: 18F-fluorodeoxyglucose positron emission tomography imaging showed higher vascular inflammation in ascending aorta of psoriasis patients as compared to historical controls. Systemic treatment with methotrexate and pioglitazone did not influence the vascular inflammation in the short term.

Chemoprophylaxis of leprosy with rifampicin in contacts of multibacillary patients: study protocol for a randomized controlled trial.

BACKGROUND: The annual new-case detection rate for leprosy, while generally stable over the last decade, shows that transmission rates have remained stagnant despite the successful worldwide administration of multidrug therapy since the 1980s. As such, novel control strategies are urgently needed. Focusing on managing leprosy patient contacts, the most susceptible to contracting the disease, has been seen as a potential strategy in limiting the spread of leprosy as shown by a number of recent epidemiological studies. Immunoprophylaxis with Bacillus Calmette-Guérin (BCG) has been seen as an effective preventive measure due to its ability to stimulate the development of cellular immunity which is essential in controlling the disease, especially in its multibacillary (MB) forms. The association of immunoprophylaxis with chemoprophylaxis in a single dose of rifampicin has been shown to be a promising preventive strategy, although a variety of studies have found instances of early case detection just a few months after BCG vaccination. METHODS/DESIGN: The present study is a phase IV chemoprophylactic clinical trial consisting of administration of a single dose of rifampicin in MB leprosy patient contacts under care at the Souza Araújo Outpatient Clinic/FIOCRUZ as part of a randomized (2:1), double-blind, placebo-controlled study. It is comprised of two groups: 1) rifampicin + BCG; and 2) placebo + BCG. DISCUSSION: The aim is to evaluate whether the use of chemoprophylaxis with a single dose of rifampicin in MB leprosy patient contacts prior to the BCG vaccine would be able to prevent the onset of leprosy in those cases that may occur just a few months after vaccination. Contact subclinical infections (polymerase chain reaction) and the immunological parameters (anti-PGL-1, anti-LID-1, and IFN-γ) will be evaluated and the results will be compared after 12 months of follow-up. TRIAL REGISTRATION: The Brazilian Registry of Clinical Trials (ReBEC), RBR-69QK5P . Retrospectively registered on 1 June 2017.

Percutaneous ethanol injection as a promising and minimally invasive treatment for axillary osmidrosis: Double-blinded randomized controlled trial.

BACKGROUND: Axillary osmidrosis is a common problem with a strong negative impact on the professional and social quality of life. Several options are available for its treatment. But there are no treatment guidelines. The objective of this study was to evaluate efficacy and safety of percutaneous ethanol injection for treatment of axillary osmidrosis. METHODS: A randomized, double-blind, placebo-controlled clinical trial to assess clinical efficacy and postoperative complications of percutaneous ethanol injection was performed among 60 patients (12-35 years of age) with axillary osmidrosis. The active agent used in the experimental group (n = 30) was sterile 90% ethanol and the placebo used in the control group (n = 30) was sterile normal saline administered in an identical syringe. The results of malodor elimination were graded by the patients as excellent, good, fair, and poor. All patients were followed-up for 10 months. RESULTS: Malodor elimination was graded as good by 15 (50%) patients treated with percutaneous ethanol injection. A significant difference in the improvement of axillary osmidrosis was found between the experimental and control groups (P < 0.001). The most common post-procedure complication was transient subjective skin stiffness in the experimental group, which regressed spontaneously. There were no serious permanent side effects. LIMITATIONS: Relatively short duration of follow-up; and lack of histopathological evidence of destruction of the apocrine glands after treatment in most patients. CONCLUSIONS: Percutaneous ethanol injection is an effective and safe treatment method for axillary osmidrosis and does not have permanent side effects.