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The Journal of Dermatological Treatment Dec 2024This study aims to assess the efficacy and safety of combining the 308-nm Excimer lamp with Tacrolimus 0.1% ointment, compared to Tacrolimus 0.1% ointment monotherapy,... (Randomized Controlled Trial)
Randomized Controlled Trial
Efficacy and safety of 308-nm Excimer lamp combined with Tacrolimus 0.1% ointment vs Tacrolimus 0.1% ointment as monotherapy in treating children with limited vitiligo: a randomized controlled trial.
OBJECTIVE
This study aims to assess the efficacy and safety of combining the 308-nm Excimer lamp with Tacrolimus 0.1% ointment, compared to Tacrolimus 0.1% ointment monotherapy, for treating pediatric vitiligo involving less than 10% of the body surface area.
METHODS
Fifty pediatric patients with vitiligo were randomly assigned to two groups. Group A received Tacrolimus 0.1% ointment twice daily and Excimer light at 308-nm twice weekly, while Group B received Tacrolimus 0.1% ointment alone, administered twice daily. Repigmentation percentages were evaluated after 30, 90, and 180 days using the rule of nine.
RESULTS
Group A exhibited a significant improvement in repigmentation, increasing from 10% after one month to 65% after six months. In contrast, Group B observed an increase from 10% to 30% over the same timeframe. The efficacy of the treatment was significantly higher in Group A at both the 3-month and 6-month follow-up points (-value < .001). Moreover, Group A achieved notably higher repigmentation rates in the face, trunk, and lower limbs.
CONCLUSION
The combination of Tacrolimus and the 308-nm excimer lamp yielded superior repigmentation results compared to Tacrolimus monotherapy in pediatric vitiligo patients. This combined approach may offer an effective new treatment protocol for pediatric vitiligo.
Topics: Child; Humans; Combined Modality Therapy; Ointments; Tacrolimus; Treatment Outcome; Vitiligo
PubMed: 38124534
DOI: 10.1080/09546634.2023.2296851 -
Drug Design, Development and Therapy 2016Vitiligo is a repugnant and odious dermatological malady of the time. It has an detrimental impact on the pigmentation of the human skin as a result of the destruction...
BACKGROUND
Vitiligo is a repugnant and odious dermatological malady of the time. It has an detrimental impact on the pigmentation of the human skin as a result of the destruction of cutaneous melanocytes. It affects 1%-2% of the population worldwide. Different therapeutic regimens have been deployed to treat vitiligo, but none of them could stand alone to be stated as a perfect cure. Recently, a change has been observed through novel experimental-designed optimization leading to the development of an anti-vitiligo ointment containing (PC) seed powder.
AIM
The aim of this study was to explore the clinical outcomes of ointment containing powdered seeds of PC.
MATERIALS AND METHODS
Guided by the protocol Response Surface Methodology, 13 formulations of concentration variance of permeation enhancers were prepared. The formulation fulfilling the required criteria (pH; temperature stability tests at 8°C±0.1°C, 25°C±0.1°C and 40°C±0.1°C; and the physical properties such as color, bleeding and rheology) was selected for clinical trials. Fourier transform infrared spectroscopy studies of seed powder of PC and selected formulation of the seed powder were performed. After obtaining informed consents and with prior approval of university and hospital ethical review boards, 20 patients (age range 25-65 years) were included in the present study. Formulations were applied on the affected body parts of patients, and some affected portion of the same patient was taken as control (self-control study design). The pigmentation of white spots of vitiligo was photographically evaluated before, during and after 12 weeks of treatment. Analysis of the measured values was performed using GraphPad Prism version 5 statistical software. A paired sample -test was performed to observe variation between repigmented patches and white patches of self-control.
RESULTS
Hydrophilic ointment (10% w/w) prepared with seed powder of PC was fabricated. The ointment was found effective for small circular white lesions of vitiligo as compared to self-control. Pre- and post-treatment differences in the levels of pigmentation were statistically significant (≤0.05).
CONCLUSION
Ointment containing seed powder of PC could be an effective monotherapy for small circular white lesions of vitiligo.
Topics: Candidiasis, Cutaneous; Humans; Ointments; Psoralea; Vitiligo
PubMed: 27920496
DOI: 10.2147/DDDT.S114328 -
American Journal of Clinical Dermatology Jul 2022Chlormethine gel was approved for treatment of mycosis fungoides, the most common cutaneous T-cell lymphoma, on the basis of results from study 201 and study 202. A...
BACKGROUND
Chlormethine gel was approved for treatment of mycosis fungoides, the most common cutaneous T-cell lymphoma, on the basis of results from study 201 and study 202. A post-hoc analysis of study 201 found interesting trends regarding improved efficacy of chlormethine gel vs ointment and noted a potential association between dermatitis and clinical response.
OBJECTIVE
To expand these results by performing a post-hoc analysis of study 202.
PATIENTS AND METHODS
Patients received chlormethine gel or ointment during study 201 (12 months) and higher-concentration chlormethine gel during study 202 (7-month extension). Response was assessed using Composite Assessment of Index Lesion Severity (CAILS). Associations between treatment frequency, response, and skin-related adverse events (AEs) were assessed using multivariate time-to-event analyses. Time-to-response and repeated measures analyses were compared between patients who only used chlormethine gel and those who switched from ointment to gel.
RESULTS
No associations were seen between treatment frequency and improved skin response (CAILS) or AE occurrence within the 201/202 study populations. However, an association was observed specifically between contact dermatitis and improved CAILS response at the next visit (p < 0.0001). Patients who used chlormethine gel during both studies had a significantly (p < 0.05) shorter time to response and higher overall response rates than patients who initiated treatment with ointment.
CONCLUSIONS
This post-hoc analysis shows that patients who initiated treatment using chlormethine gel had faster and higher responses compared with patients who initially used chlormethine ointment for 12 months. The development of contact dermatitis may be a potential prognostic factor for response.
TRIAL REGISTRATION NUMBERS AND DATES OF REGISTRATION
Study 201: NCT00168064, September 14, 2002; Study 202: NCT00535470, September 26, 2007.
Topics: Clinical Trials as Topic; Dermatitis, Contact; Gels; Humans; Mechlorethamine; Mycosis Fungoides; Ointments; Skin Neoplasms; Treatment Outcome
PubMed: 35536441
DOI: 10.1007/s40257-022-00687-y -
Forensic Toxicology Jan 2022Drug distribution in scalp hair can provide historical information about drug use, such as the date and frequency of drug ingestion. We previously developed...
Distribution profiles of diphenhydramine and lidocaine in scalp, axillary, and pubic hairs measured by micro-segmental hair analysis: good indicator for discrimination between administration and external contamination of the drugs.
PURPOSE
Drug distribution in scalp hair can provide historical information about drug use, such as the date and frequency of drug ingestion. We previously developed micro-segmental hair analysis, which visualizes drug distribution at 0.4-mm intervals in individual hairs. The present study examines whether the distribution profiles of drugs can be markers for the administration or external contamination of the drugs using scalp, axillary, and pubic hairs.
METHODS
A single dose of anti-itch ointment containing diphenhydramine (DP) and lidocaine (LD) was topically applied to the axillary or pubic areas of two volunteers; DP was also orally administered; and LD was intra-gingivally injected. Scalp, axillary, and pubic hairs were assessed using our micro-segmental analysis.
RESULTS
The localization of DP and LD differed within individual scalp hair strands, implying DP and LD were predominantly incorporated into scalp hair via the bloodstream and via sweat/sebum, respectively, showing double-peak profiles. However, DP and LD were distributed along the shafts of axillary and pubic hairs without appearance of the double-peak profiles when the ointment had been applied to the axillary and pubic areas. The distributions of DP and LD in scalp hairs did not significantly differ according to administration routes, such as oral administration, gingival injection, and topical application.
CONCLUSIONS
Micro-segmental analysis revealed differences in the distribution profiles of drugs in hairs, and distinguished hairs with and without external contamination. These findings will be useful for understanding of the mechanism of drug uptake into hair and for estimating the circumstances for a drug use.
Topics: Humans; Scalp; Diphenhydramine; Pharmaceutical Preparations; Lidocaine; Ointments; Hair; Emollients
PubMed: 36454485
DOI: 10.1007/s11419-021-00590-x -
Journal of Evidence-based Integrative... 2022Joint pain is a common ailment among adults worldwide. Six men and 14 women (aged 51 ± 10 years) with self-reported joint pain were randomly assigned, using a... (Randomized Controlled Trial)
Randomized Controlled Trial
Joint pain is a common ailment among adults worldwide. Six men and 14 women (aged 51 ± 10 years) with self-reported joint pain were randomly assigned, using a cross-over design, to a botanical ointment (Yeahhh Baby!®) or placebo, twice daily for 14 days. Subjects completed questionnaires regarding their joint pain and discomfort (eg, WOMAC and subjective pain using a visual analog scale [VAS]) each evening and underwent a washout period of two weeks before crossing into the other condition. Pain and discomfort scores improved for subjects when using Yeahhh Baby!® ointment from day 1 to the average of days 2-15. For certain measures, similar, albeit insignificant, improvements were noted when subjects used the placebo-demonstrating the powerful placebo effect. Specifically, with Yeahhh Baby!® ointment, effects were noted for WOMAC pain ( = .008), WOMAC physical function ( = .024), WOMAC total ( = .019), and VAS mood interference ( = .042). The most pronounced improvement was noted for WOMAC pain ( = .048), with a 25% reduction observed with Yeahhh Baby!®, with a 10% reduction noted for placebo. These findings indicate that, as compared to a placebo, Yeahhh Baby!® ointment may provide relief to individuals suffering from joint pain in their knees and/or hips.
Topics: Male; Adult; Humans; Female; Self Report; Osteoarthritis, Knee; Ointments; Double-Blind Method; Treatment Outcome; Pain; Arthralgia
PubMed: 36412015
DOI: 10.1177/2515690X221138824 -
Acta Bio-medica : Atenei Parmensis Feb 2021A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the...
The effect of sucralfate-containing ointment on quality of life in people with symptoms associated with haemorrhoidal disease and its complications: the results of the EMOCARE survey.
BACKGROUND AND AIM
A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease. This survey evaluated the effect of the mentioned sucralfate ointment, on quality of life (QoL) and symptom frequency in participants seeking treatment for haemorrhoidal disease from community pharmacies in Italy.
METHODS
EMOCARE was a multicentre prospective survey conducted at community pharmacies in Italy. Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile). A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment. The primary endpoint was the change in HEMO-FISS-QoL scores.
RESULTS
Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit. After a mean duration of 13 days, the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: -10.41; 95%CI -11.95, -8.86; P<0.001) and mean scores for all domains of the HEMO-FISS-QoL scale (-11.13 [95%CI -12.95, -9.30] for physical disorders, -6.14 [95%CI -7.42, -4.85] for psychology, -18.79 [95% CI -21.67, -15.90] for defaecation, and -6.46 [95%CI -8.40, -4.51] for sexuality; all P<0.001 versus baseline). At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms and the frequency of all assessed symptoms were reduced significantly from baseline (all P<0.05).
CONCLUSIONS
After a mean 13 days of treatment the sucralfate ointment with herbal extracts improved HEMO-FISS-QoL scores and reduced symptoms in people with haemorrhoidal disease.
Topics: Female; Hemorrhoids; Humans; Italy; Male; Middle Aged; Ointments; Prospective Studies; Quality of Life; Sucralfate
PubMed: 33683221
DOI: 10.23750/abm.v92i1.11309 -
Cirugia Y Cirujanos 2023To compare the protective effect of nitroglycerin ointment 2% and Dimethylsulfoxide (DMSO) in dorsal flaps of the rat.
OBJECTIVE
To compare the protective effect of nitroglycerin ointment 2% and Dimethylsulfoxide (DMSO) in dorsal flaps of the rat.
METHODS
A blind, experimental study was conducted in 24 male Wistar rats, with a mean weight of 320 (286-376) grams. Group 1: Control. Petrolatum jelly (Vaseline), n = 8, Group 2: Nitroglycerin (NTG) ointment 2% (Nitro-Bid, Altana Co.) n = 8, and Group 3: DMSO gel 90% (Neogen corp. Lexington KY, 40611), n = 8.
RESULTS
A total of 24 rats were operated on in the 6-month period of this study. Using a non-parametric Mann-Whitney U-test analysis, a statistically significant p was obtained between the control group and 2% NTG ointment, both in the area of necrosis and in the healthy area (p = 0.026). In contrast, the comparison between DMSO [CH3) 2SO] and the control group (p = 0.180) and between both study groups, with a p = 0.18, was not significant.
CONCLUSIONS
Our study concluded that there is a protective effect of 2% NTG ointment for flap survival in relation to the control group (petrolatum). DMSO administered topically did not show a protective effect, compared to the control group.
Topics: Rats; Male; Animals; Nitroglycerin; Dimethyl Sulfoxide; Ointments; Rats, Wistar; Necrosis; Petrolatum
PubMed: 37844881
DOI: 10.24875/CIRU.22000203 -
Academic Emergency Medicine : Official... Jan 1995
Topics: Anti-Bacterial Agents; Contraindications; Humans; Ointments; Postoperative Period; Wound Healing; Wound Infection
PubMed: 7606605
DOI: 10.1111/j.1553-2712.1995.tb03069.x -
The Cochrane Database of Systematic... Dec 2014Leading health authorities all recommend exclusive breastfeeding to six months' postpartum. While most women initiate breastfeeding, many discontinue due to difficulties... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Leading health authorities all recommend exclusive breastfeeding to six months' postpartum. While most women initiate breastfeeding, many discontinue due to difficulties encountered rather than maternal choice. One common breastfeeding difficulty is painful nipples. Research has identified poor infant positioning or latch as a common cause of painful nipples. While many different interventions designed to reduce nipple pain in breastfeeding women have been evaluated, it is unclear which intervention is the most effective treatment. An understanding of nipple pain and treatment options are needed to improve breastfeeding duration and exclusivity rates and to address systematically one of the most frequent difficulties encountered by breastfeeding women.
OBJECTIVES
To assess the effects of all interventions in the resolution or reduction of nipple pain and the impact of the interventions on other outcomes such as nipple trauma, nipple infections, breast mastitis, breastfeeding duration, breastfeeding exclusivity, and maternal satisfaction.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2014) and scanned secondary references.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials designed to evaluate any intervention for treating nipple pain among breastfeeding women. Trials using a cluster-randomised design were eligible for inclusion. Cross-over trials were not eligible for inclusion. The following interventions were eligible for inclusion compared with each other or usual care (i.e. education only): pharmacological (e.g. antifungal creams); non-pharmacological topical treatments (e.g. lanolin); dressings (e.g. hydrogel dressings); nipple protection devices (e.g. breast shells), phototherapy, and expressed breast milk. Nipple pain in women who are feeding with expressed breast milk (i.e. women of infants in neonatal units) is associated with other methods of removing milk from the mother's breast such as manual expression and various types of breast pumps. Nipple pain and subsequent treatment is different in this unique maternal population and thus we excluded women solely feeding with expressed breast milk from this review.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data, evaluated methodological quality, and checked data for accuracy. We sought additional information from several trial researchers.
MAIN RESULTS
We included four trials of good methodological quality involving 656 women in the review. The four included trials evaluated five different interventions including glycerine pads, lanolin with breast shells, lanolin alone, expressed breast milk, and an all-purpose nipple ointment. All studies included education to position the infant at the breast correctly as part of routine postpartum care to both treatment and control groups.Pooled data existed only for the comparison of lanolin versus usual care. We did not pool data for other outcomes due to either heterogeneity in outcome measures or differing interventions.There was no evidence that glycerine gel dressings or breast shells with lanolin significantly improved nipple pain. One trial found no clear differences in nipple pain (at one to three days, four to five days, or six to seven days' post-treatment) between women who applied lanolin or nothing to their nipples. In contrast, the same trial found that women who applied expressed breast milk had significantly lower perceptions of nipple pain following four to five days of treatment than women who applied lanolin. However, this beneficial effect was not maintained after six to seven days of treatment. There were no group differences in nipple pain perceptions at any assessment between women who applied expressed breast milk and women who applied nothing. Women who applied an "all-purpose nipple ointment", in comparison to women who applied lanolin, had no improvement in nipple pain after seven days of treatment. There was insufficient evidence that glycerine gel dressings, lanolin with breast shells, lanolin alone, expressed breast milk, or all-purpose nipple ointment improved maternal perceptions of nipple pain.Overall, there was insufficient evidence to recommend any intervention for the treatment of nipple pain. However, one important finding was that regardless of the treatment used, for most women nipple pain reduced to mild levels after approximately seven to 10 days' postpartum. The provision of anticipatory guidance regarding usual time to pain reduction may be a useful strategy in assisting women to continue to breastfeed and to do so exclusively. The overall quality of the evidence for the primary outcome of nipple pain as assessed using GRADE was of low quality, mainly because single studies with few participants contributed data for analysis.
AUTHORS' CONCLUSIONS
There was insufficient evidence that glycerine gel dressings, breast shells with lanolin, lanolin alone, or the all-purpose nipple ointment significantly improved maternal perceptions of nipple pain. The results from these four trials of good methodological quality suggested that applying nothing or just expressed breast milk may be equally or more beneficial in the short-term experience of nipple pain than the application of an ointment such as lanolin.The quality of the evidence for this review did not lead to robust conclusions regarding the objectives assessed. We included only four trials, incorporating 656 women, in the review and all four trials compared varying interventions, participants, study outcome measures, and standards of usual care. The methodological quality of the included studies was good but the overall quality of the evidence for the primary outcome of nipple pain was of low quality, mainly because single studies with few participants contributed data for analysis.
Topics: Bandages; Breast Diseases; Breast Feeding; Female; Gels; Glycerol; Humans; Lanolin; Milk, Human; Nipples; Ointments; Pain Management; Protective Devices; Randomized Controlled Trials as Topic
PubMed: 25506813
DOI: 10.1002/14651858.CD007366.pub2 -
Chemical & Pharmaceutical Bulletin 2015White petrolatum is a mixture of solid and liquid hydrocarbons and its structure can be affected by shear stress. Thus, it might also induce changes in its rheological...
Effects of mixing procedure itself on the structure, viscosity, and spreadability of white petrolatum and salicylic acid ointment and the skin permeation of salicylic acid.
White petrolatum is a mixture of solid and liquid hydrocarbons and its structure can be affected by shear stress. Thus, it might also induce changes in its rheological properties. In this study, we used polarization microscopy to investigate how different mixing methods affect the structure of white petrolatum. We used two different mixing methods, mixing using a rotation/revolution mixer and mixing using an ointment slab and an ointment spatula. The extent of the fragmentation and dispersal of the solid portion of white petrolatum depended on the mixing conditions. Next, we examined the changes in the structure of a salicylic acid ointment, in which white petrolatum was used as a base, induced by mixing and found that the salicylic acid solids within the ointment were also dispersed. In addition to these structural changes, the viscosity and thixotropic behavior of both test substances also decreased in a mixing condition-dependent manner. The reductions in these parameters were most marked after mixing with a rotation/revolution mixer, and similar results were obtained for spreadability. We also investigated the effects of mixing procedure on the skin accumulation and permeation of salicylic acid. They were increased by approximately three-fold after mixing. Little difference in skin accumulation or permeation was detected between the two mixing methods. These findings indicate that mixing procedures themselves affect the utility and physiological effects of white petrolatum-based ointments. Therefore, these effects should be considered when mixing is required for the clinical use of petrolatum-based ointments.
Topics: Animals; Drug Compounding; Ointments; Petrolatum; Rheology; Salicylic Acid; Skin; Skin Absorption; Swine; Viscosity
PubMed: 25400272
DOI: 10.1248/cpb.c14-00558