Aqueous Cream Research Articles

Keratin gel improves poor scarring following median sternotomy.

Linear hypertrophic scarring is a common surgical problem that can be difficult to manage. This article evaluates median sternotomy wounds that have often been reported to scar poorly resulting in hypertrophic scar formation. This study is a single-blinded, open-labelled pilot study of 20 patients using keratin gel as the intervention and aqueous cream as the control, which are each applied to a different half of the wound daily over 6 months. We use the Patient and Observer Scar Assessment Scale (POSAS) and the Manchester Scar Score (MSS) to assess the scarring. At the 6-month assessment the MSS, patient-POSAS and observer-POSAS were 12.00, 16.70 and 15.00 in the treatment half and 12.58, 17.85 and 16.55 in the control half respectively. Overall, we found that there was a decrease in all score scales after 6 months (P = 0.005). Furthermore, in the subset of patients with poor scarring, decreases in the MSS, patient-POSAS and observer-POSAS were statistically significant (P = 0.025, <0.01 and 0.01) with scores of 12.22, 17.33 and 15.33 in the treatment half and 14.22, 23.67 and 22.33 in the control half respectively. In patients who scar more poorly than average, there were significant improvements in scarring. This demonstrates a simple, well-tolerated intervention that reduces problematic scarring following surgery.

Topical Cream-Based Dosage Forms of the Macrocyclic Drug Delivery Vehicle Cucurbit[6]uril

The macrocycle family of molecules called cucurbit[n]urils are potential drug delivery vehicles as they are able to form host-guest complexes with many different classes of drugs. This study aimed to examine the utility of Cucurbit[6]uril (CB[6]) in topical cream-based formulations for either localised treatment or for transdermal delivery. Cucurbit[6]uril was formulated into both buffered cream aqueous- and oily cream-based dosage forms. The solid state interaction of CB[6] with other excipients was studied by differential scanning calorimetry and the macrocycle's transdermal permeability was determined using rat skin. Significant solid state interactions were observed between CB[6] and the other dosage form excipients. At concentrations up to 32% w/w the buffered aqueous cream maintained its normal consistency and could be effectively applied to skin, but the oily cream was too stiff and is not suitable as a dosage form. Cucurbit[6]uril does not permeate through skin; as such, the results imply that cucurbituril-based topical creams may potentially only have applications for localised skin treatment and not for transdermal drug delivery.

Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients

PurposeSafetac-based soft silicone dressings used in a management setting decrease the severity of radiation-induced acute skin reactions but do not affect moist desquamation rates. Here we investigate the prophylactic use of another Safetac product, Mepitel Film, on moist desquamation rates. Material and methodsA total of 80 breast cancer patients receiving radiation therapy were recruited between October 2012 and April 2013; 78 participants contributed data for analysis. Lateral and medial halves of the skin areas to be irradiated were randomised to Mepitel Film or aqueous cream; skin dose was measured using thermoluminescent dosimeters; skin reaction severity was assessed using RISRAS and RTOG scales. ResultsOverall skin reaction severity was reduced by 92% (p<0.0001) in favour of Mepitel Film (RISRAS). All patients developed some form of reaction in cream-treated skin which progressed to moist desquamation in 26% of patients (RTOG grades I: 28%; IIA: 46%; IIB: 18%; III: 8%). Only 44% of patients had a skin reaction under the Film, which did not progress to moist desquamation in any of the patients (RTOG grades I: 36%; IIA: 8%). ConclusionsMepitel Film completely prevented moist desquamation and reduced skin reaction severity by 92% when used prophylactically in our cohort.

The aqueous cream controversy

The aqueous cream controversy

ZeroAQS Cream: a cost-effective and SLS-free alternative to aqueous cream

ZeroAQS Cream: a cost-effective and SLS-free alternative to aqueous cream

HPLC Method for the Simultaneous Determination of the UV-Filters Butyl Methoxy Dibenzoylmethane and Octocrylene in the Presence of Their Photodegradants

Butyl methoxy dibenzoylmethane (BMDM) and octocrylene (OC), common UV-filters in sunscreen products are often used in combination. Together they provide broad spectrum photoprotection from exposure to both UVA- and UVB-light. These UV-filters may, however, undergo photodegradation and generate photodegradants, resulting in a potential loss of photoprotection. It is thus a concern that the photostability testing as described by the ICH Guideline Q1B is not a requirement for sunscreen products in Australia, Europe or the USA. UV-filter photodegradants have in addition been shown to be toxic, highlighting the importance of their separation from the parent UV-filters. An HPLC method was developed and validated to quantitatively determine a combination of these UV-filters in the presence of their photodegradants. Reverse-phase chromatography was employed, using a C18 column and an isocratic mobile phase consisting of methanol/water/acetic acid (89/10/1 v/v). Validation according to the ICH guidelines for linearity, accuracy, precision, sensitivity, specificity and robustness was confirmed. The developed and validated method was then successfully applied to the determination of BMDM and OC in an aqueous cream base, typically used in sunscreens, after photostability testing, according to the ICH Guideline Q1B. In addition, the diketo-enol ratio of BMDM in methanol-d4 was determined by NMR and the two major photodegradants were identified by FTMS and LC–MS.

A pilot randomised trial of Medilixir cream shows some promising results, but control treatment may have been inappropriate

Aim To test the efficacy of Medilixir [cream] against the standard treatment of aqueous cream in the provision of relief from the symptoms of postburn itch. Design RCT with two parallel arms. Setting Professor Stuart Pegg Adult Burns Centre, Royal Brisbane and Women's Hospital, Brisbane, Australia. Participants Fifty-two patients aged between 18 and 80 years, admitted directly to the burns centre between 10 March and 22 July 2008, were able to provide informed consent, and had shown no allergic reaction to a patch test with the study medication, were randomised. Patients admitted from intensive care or high dependency were excluded. Main results Effect estimates and confidence intervals were not reported for any of the outcomes; only group means/proportions and P-values from hypothesis testing were provided. More patients in the intervention group reported itch reduction compared to comparison treatment (91 vs. 82%, P=0.001). Itch recurrence after cream application occurred later in the intervention group compared to the control group (P<0.001). Use of antipruritic medication was significantly greater in the control group (P=0.023). There was no difference in sleep disturbance between groups (not quantified). On average, Medilixir took longer to apply than aqueous cream (157s for Medilixir vs. 139s for aqueous cream; mean difference 17s), but authors noted that the groups did not differ significantly (CI for mean difference and P-values were not reported).

Randomized Intra-Patient Controlled Trial of Mepilexlite Dressings vs. Aqueous Cream in Managing Radiation-Induced Skin Reactions Post-Mastectomy

Randomized Intra-Patient Controlled Trial of Mepilexlite Dressings vs. Aqueous Cream in Managing Radiation-Induced Skin Reactions Post-Mastectomy

It's A Kind Of Magic! The Unexpected Impact of a Systematic In-Patient Controlled Clinical Trial on Patient Well-Being

Breast cancer is the most common malignancy for women in New Zealand, the majority receiving radiation therapy as part of their treatment regimen. Radiation-induced skin toxicities occur in a large proportion of patients yet currently there is no standard treatment for them, practice largely being based on historical and anecdotal evidence. As radiation therapy techniques become increasingly complex and practice focuses on the greater good of the patient, some crossing of professional boundaries will occur. In a first for New Zealand, we instigated radiation therapist (RT)-led on-treatment review clinics for breast cancer patients which saw us step into an area that is traditionally considered the domain of medics. This led to clinical trials, initiated and managed by RTs, aimed at providing the authentication for our emerging evidence-based practice. One trial in particular had significant ramifications for our practice. The randomised controlled multi-centre trial compared the efficacy of silicon foam dressing with the standard treatment of aqueous cream. A total of 104 patients were enrolled, the majority receiving 50Gy in 25 fractions. Toxicities were assessed three times a week using the Radiation-Induced Skin Reaction Scale with patients doubling as their own controls to eliminate confounding patient and treatment-related factors. The trial endpoint was moist desquamation (MD). Statistical analysis, using ANOVA design of repeated measurement of paired patches together with the non-parametric Wilcoxon signed rank test, clearly demonstrated a significant toxicity decrease (42%; p<0.001). An intriguing incongruity emerged when the percentage of our patients progressing to MD - 14% control; 0% trial area - was compared with those from other centres - 44% control; 24% trial area. Analysis of this disparity resulted in a substantial change in our practice, allowing us to capitalise on these enhanced patient outcomes. Further research examining the correlation between the levels of holistic care afforded to patients and the intensity of reactions experienced/observed is also underway.

Polysaccharides-Rich Extract ofGanoderma lucidum(M.A. Curtis:Fr.) P. Karst Accelerates Wound Healing in Streptozotocin-Induced Diabetic Rats

Ganoderma lucidum (M.A. Curtis:Fr.) P. Karst is a popular medicinal mushroom. Scientific reports had shown that the wound healing effects of G. lucidum were partly attributed to its rich polysaccharides. However, little attention has been paid to its potential effects on wounds associated with diabetes mellitus. In this study, we evaluated the wound healing activity of the hot aqueous extract of G. lucidum in streptozotocin-induced diabetic rats. The extract of G. lucidum was standardised based on chemical contents (w/w) of total polysaccharides (25.1%), ganoderic acid A (0.45%), and adenosine (0.069%). Six groups of six rats were experimentally wounded in the posterior neck region. Intrasite gel was used as a positive control and aqueous cream as the placebo. Topical application with 10% (w/w) of mushroom extract-incorporated aqueous cream was more effective than that with Intrasite gel in terms of wound closure. The antioxidant activity in serum of rats treated with aqueous extract of G. lucidum was significantly higher; whereas the oxidative protein products and lipid damage were lower when compared to those of the controls. These findings strongly support the beneficial effects of standardised aqueous extract of G. lucidum in accelerating wound healing in streptozotocin-induced diabetic rats.

Recommend alternative to aqueous cream if irritation occurs

Recommend alternative to aqueous cream if irritation occurs

No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions – Results from a randomised blinded trial

PurposeThe purpose of this blinded, randomized clinical trial was to compare two topical agents (Calendula Weleda® cream vs. Essex® cream) in reducing the risk of severe acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast cancer. MethodThe primary endpoint was the difference in proportion of patients with ARSR, assessed with the Radiation Therapy Oncology Group/The Organization for Research and Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at follow-up. The secondary endpoints included patient reported outcome measures; Quality of Life Questionnaire (QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms from the irradiated area (visual analogue scale). Patients' experiences and adherence to the topical agents were also evaluated. ResultsA total of 420 patients were randomised and 411 were analysed. With the exception of previous chemotherapy, the treatment groups were well balanced, both regarding treatment- and patient-related factors. The incidence of severe ARSR (RTOG/EORTC grade ≤2) at the follow-up visit was 23% (n = 45) in the Calendula group and 19% (n = 38) in the Essex group. We found no difference in severe ARSR between the groups at any point of assessment. The patients reported low levels of skin related symptoms and no statistically significant differences between the groups were found. ConclusionsNo differences in ARSR between patients randomised to Calendula or Essex cream was found. ARSR seem to be a relatively limited problem, probably more influenced by treatment related factors than by choice of skin care products in this patient group.

Evaluation of the Antibacterial activity of Herbal ointments formulated with Methanolic extract of Cassia alata

In this study, the antibacterial potency of herbal ointments formulated with methanolic extract of Cassia alata was evaluated. The preliminary in vitro antibacterial activity of the methanolic extracts of sun-dried leaves of Cassia alata was determined against Staphylococcus aureus, Bacillus subtilis, Escherichia coli and Pseudomonas aeruginosa using the Agar cup plate method. The antibacterial activity of the extract was predominantly against Gram-positive organisms. Herbal ointments were prepared by incorporating the methanolic extract of Cassia alata (10 % w/w) into aqueous cream, emulsifying ointment and simple ointment bases and evaluated for their in vitro antibacterial efficacy. The formulation containing Cassia alata extract in aqueous cream showed comparatively better antibacterial activity than the other formulations in the following order: aqueous cream > emulsifying ointment > simple ointment > crude extract. The herbal ointment also compared favourably with a commercial brand of Gentamicin ointment. This study shows that Cassia alata has antibacterial activity and also has high potential as antibacterial agent when formulated as ointment for topical use and could therefore explain the successes claimed in the folk use of the plant in the treatment of common skin conditions.

Use of Amitriptyline Cream in the Management of Entry Dyspareunia Due to Provoked Vestibulodynia

This study aimed to evaluate the effectiveness of topical amitriptyline 2% in sorbolene (cetomacrogol aqueous) cream in the management of patients with entry dyspareunia caused by provoked vestibulodynia. A prospective study of 150 patients presenting with entry dyspareunia to a private gynecologist (R.P.) was undertaken during a 12-month period. Provoked vestibulodynia was diagnosed by the presence of pinpoint tenderness confined to the vulvar vestibule. Most patients (102) had purely provoked vestibulodynia, whereas 48 had both provoked and unprovoked pain. There were 7 patients with grade 1 dyspareunia (intercourse always painful but only occasionally preventing penetration), 83 patients with grade 2 (intercourse always painful preventing penetration on most occasions), and 60 patients with grade 3 (apareunic). Questionnaires were evaluated before and 3 months after commencement of treatment. No control group using placebo was studied because of the private-practice setting. Duration of symptoms varied from 1 to 30 years, the mean being 4.7 years. There was no response in 66 patients (44%). Of these, 16 patients ceased treatment early because of local skin irritation and hence were regarded as treatment failures. The 84 patients (56%) that responded were divided into 3 groups as follows: (i) 25 with a slight but noticeable improvement; (ii) 44 with a moderate degree of improvement; and (iii) 15 with an excellent response, describing intercourse as comfortable and pain free (10% of the total study group). Most patients in all 3 groups elected to continue application of the cream after completion of the study. The response rate was similar (48%) in the subgroup that also had unprovoked vestibulodynia. There was no difference in the response rate according to parity. The response rate was also similar in patients who had previously taken oral amitriptyline unsuccessfully. In these 44 patients, the overall response rate was 59%. Topical amitriptyline cream should be considered for first-line treatment in the management of patients with provoked vestibulodynia causing entry dyspareunia. The response rate is reasonable (56%), and it eliminates the problems with systemic administration, namely, drowsiness and the difficulty patients have in accepting antidepressant medication for their condition.

Objective and subjective in vivo comparison of two emollient products

BackgroundFew studies have directly compared the effectiveness of different emollients in vivo, and the important matter of patient preference is generally overlooked.MethodsWe report the results of an assessor-blinded, bilateral, concurrent comparison of two emollient pharmaceutical presentations, ie, Doublebase gel (DB) and Aqueous cream BP (AC), applied by 20 participants three times daily for 7 consecutive days. The primary efficacy endpoint was cumulative improvement in skin hydration measured by corneometry on days 1, 3, and 5 immediately before the first application and approximately 2 hours after the third application of the day. Secondary endpoints were investigator assessment of skin condition at these time points and participant assessment of product acceptability at the end of the study.ResultsBoth products increased skin hydration, but the effect of AC was relatively modest, with morning values readily returning to pretreatment levels. Hydration levels were higher for DB gel, maintained at all time points, and showed stepwise, cumulative increases over the 7 days of use. Overall patient satisfaction scores were higher for DB gel, and especially for “consistency,” “ease of use,” and “ease of absorption into the skin.” Eighty-five percent of participants expressed a desire to use DB gel again as compared with 40% for AC.

A double-blind randomised controlled trial of a natural oil-based emulsion (Moogoo Udder Cream®) containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer

BackgroundRadiation-induced skin reaction (RISR) is one of the most common and distressing side effects of radiotherapy in patients with cancer. It is featured with swelling, redness, itching, pain, breaks in skin, discomfort, and a burning sensation. There is a lack of convincing evidence supporting any single practice in the prevention or management of RISR.Methods/DesignsThis double-blinded randomised controlled trial aims to investigate the effects of a natural oil-based emulsion containing allantoin (as known as Moogoo Udder Cream®) versus aqueous cream in reducing RISR, improving pain, itching and quality of life in this patient group. One group will receive Moogoo Udder Cream®. Another group will receive aqueous cream. Outcome measures will be collected using patient self-administered questionnaire, interviewer administered questionnaire and clinician assessment at commencement of radiotherapy, weekly during radiotherapy, and four weeks after the completion of radiotherapy.DiscussionDespite advances of radiologic advances and supportive care, RISR are still not well managed. There is a lack of efficacious interventions in managing RISR. While anecdotal evidence suggests that Moogoo Udder Cream® may be effective in managing RISR, research is needed to substantiate this claim. This paper presents the design of a double blind randomised controlled trial that will evaluate the effects of Moogoo Udder Cream® versus aqueous cream for managing in RISR in patients with cancer.Trial registrationACTRN 12612000568819

Treatment of radiation-induced mucocutaneous toxicity

During radiotherapy 80% to 90% of all patients will develop some degree of inflammation symptoms, such as erythema, dry or wet desquamation, skin folds, or mucositis depending on radiation-and patient-related factors and the extent of irradiated skin or mucosal areas. Up to now radiation induced local reactions represent still an important toxicity factor. Cutaneous and mucosal side effects may reduce the patient's compliance and can be limiting factors to follow radiotherapy protocols. Therefore, there is a high need for effective prophylactic and therapeutic treatments. Basically, guidelines recommend the avoidance of mechanical, chemical and thermal irritants, especially the exposure to high temperatures. To delay onset of radiodermatitis various preventive topicals may be applied like aqueous cream formula with or without antioxidative agents. In general, the treatment of radiodermatitis primarily should maintain moisture and skin permeability and consists of hydrophilic creams, antioxidative and anti-inflammatory topicals. Hydrocolloid dressings may reduce and improve wound healing in grade 2 and 3 reactions. Supportive therapy of radiation-induced mucositis includes the maintenance of oral care protocols and adequate nutrition during the course of treatment. A sufficient oral health status is one of the most important factors for prevention of severe oral complications. The MASCC guidelines recommend furthermore the use of non-medicated rinses with saline or sodium bicarbonate 4 to 6 times daily. Further approaches suggest the use of local anaesthetics and systemic analgesics for severe mucositis. Besides local preventive agents and supportive care protocols, modern radiation treatment techniques remain the most promising intervention in reducing the degree of skin reactions.

A Randomized Controlled Pilot Study Comparing Aqueous Cream With a Beeswax and Herbal Oil Cream in the Provision of Relief From Postburn Pruritis

Postburn itch is reported to affect up to 87% of the burn population. Although treatments for postburn itch are multimodal, they remain consistently ineffective. However, recent anecdotal evidence from several outpatients at a tertiary referral hospital suggests that a cream combining beeswax and several herbal oils may be effective in the minimization of postburn itch. The aim of this study was to test the efficacy of beeswax and herbal oil cream against the standard treatment of aqueous cream in the provision of relief from the symptoms of postburn itch. A randomized controlled trial compared two groups using a visual analog scale, frequency of cream application, itch recurrence after cream application, use of antipruritic medications, and sleep disturbance to determine the effect of itch severity and duration. Fifty-two participants were enrolled in the study (84% male) with a mean age of 35 years (SD = 16) and mean burn TBSA of 7.2% (SD = 7.7). Study results found that the beeswax and herbal oil cream reduce itch after application more frequently than aqueous cream (P = .001). In addition, when managed with beeswax and herbal oil cream, participants found that their itch recurred later (P ≤ .001) and their use of antipruritic medications was lower (P = .023). Findings of this study suggest beeswax and herbal oil cream to be more effective in the minimization of postburn itch than aqueous cream. Given this, a larger study examining the efficacy of beeswax and herbal oil cream appears warranted.

Randomized Intra-patient Controlled Trial of Mepilex Lite Dressings versus Aqueous Cream in Managing Radiation-Induced Skin Reactions Postmastectomy

Objective: Severe acute radiation-induced skin reactions occur in a significant proportion of women who receive radiation therapy for breast cancer. We previously showed that Mepilex Lite dressings decreased the severity of erythema. Here we report their effect on the full range of skin reactions in 74 breast cancer patients post-mastectomy. Methods: A total of 80 women were recruited from four hospitals in New Zealand with 74 women contributing a full data set for analysis. The first skin area on the chest wall to develop erythema was randomly divided into two similar halves; one half was treated with Mepilex Lite dressings, the other half with aqueous cream. Skin reactions were assessed using the Radiation-Induced Skin Reaction Assessment Scale. Results: Compared with aqueous cream, Mepilex Lite dressings did not significantly reduce the incidence of moist desquamation but did reduce the overall severity of skin reactions by 41% (p<0.001), the average moist desquamation score by 49% (p=0.043) and the sum of the moist desquamation time for all patches by 28% from 25 to 18 weeks. Most patients preferred the dressings, found them easy to use and very comfortable to wear.

Topical Diphencyprone as an Effective Treatment for Cutaneous Metastatic Melanoma

Dear Editor: Although melanoma mortality has levelled in many countries, the incidence is still rising1. Metastatic melanoma is very resistant to standard treatment modalities, including chemotherapy and radiotherapy2. Since melanoma is known to be a very immunogenic tumour, various immune targeted therapies are under trial3. For local cutaneous melanoma metastasis, Rose Bengal, a water soluble xanthine dye, and intralesional bleomycin have been used and are under ongoing research4. Diphencyprone (DPCP) is a contact sensitizer with immunomodulator effects, commonly used for alopecia areata and warts5. DPCP was reported as an effective treatment for the local cutaneous metastatic melanoma on its own6,7 and in combination with cimetidine8 or dacarbazine and radiation therapy9. However DPCP alone as a treatment for cutaneous metastatic melanoma was reported from only one center so far6,7. We present a case of metatstatic melanoma successfully treated with DPCP. A fifty seven year old Caucasian male presented with multiple enlarging asymptomatic pink nodules on his right shin for 6 months. He had superficial spreading malignant melanoma of Breslow thickness 1.20 mm, Clark level 4 excised from his right ankle 6 years prior. On examination, he had multiple erythematous superficial and deep nodules on right shin ranging in size from 5 to 25 mm. Histological examination of the lesions confirmed melanoma, consistent with metastatic melanoma. Subsequent pelvic computed tomography scan and positron emission tomography scan showed no evidence of distant metastasis. Based upon the impression of metastatic melanoma limited to local spread, he was started on DPCP therapy. Intralesional interferon and radiation therapy were considered not suitable due to the cost, location, and extent of the disease. Initially he was sensitized with 2% DPCP in acetone in right inner upper arm. Two weeks later, he was started on 0.005% DPCP in aqueous cream weekly on the whole surface of right shin. He was instructed not to wash the area for 48 hours after the DPCP application. Subsequently the concentration of DPCP was increased to 0.01% for 3 weeks then 0.03% thereafter in order to achieve 2 to 3 days of eczematous reaction. On examination after 18 weeks of weekly DPCP application, his right shin showed moderate dry eczematous changes with no evidence of nodules. Further histological examination from the two sites of the previous nodules revealed marked spongiosis with numerous eosinophils, consistent with allergic contact dermatitis, but no evidence of melanoma. The patient has continued on the weekly 0.03% DPCP. The patient tolerated the treatment very well with no notable side effects. A previously reported case series showed variable response to DPCP among seven patients7. Later Th17 up-regulation was implicated as a mechanism for the regression of metastatic melanoma by DPCP10. However this was based on Th17 expressions of before and after treatment biopsy specimens from a single patient. Further studies are needed to characterize patients who will respond to DPCP therapy. Th17 expression was not studied in our case. It is not clear how long the treatment should continue once the metastatic melanoma clears. There are not enough cases to assess the response rate and survival benefits. Since DPCP is a relatively very cheap, safe and easily accessible medication, further trials from various centers would be warranted. DPCP should be considered by the clinicians as a treatment option for the patient with cutaneous metastatic melanoma with no distant metastases.