Lack of burning and stinging from a novel first-aid formulation applied to experimental wounds.

Antiseptic-anesthetic first aid formulations typically produce a burning or stinging sensation when used on wounds. The aim of this study was to assess the lack of sting/burn potential of a prototype first-aid wipe when applied to superficial wounds. This was a one-day, double-blind, randomized study, evaluating the stinging/burning sensation from a prototype first-aid wipe with a cellulose base containing 1.0% pramoxine HCL and 0.13% benzalkonium chloride. The study followed a direct comparison test design of four test formulations. The remaining three articles were: (a) sterile 0.9% sodium chloride (no-sting/no-burn control), (b) 3% hydrogen peroxide (first-aid sting/burn control), and (c) 70% isopropyl alcohol (second sting/burn control). The test was performed on 24 subjects. The tape stripping method was used to create four standardized wounds on the volar forearms, reaching the glistening layer. Each test article was applied to the wound for 15 seconds. The subjects were asked to report the intensity of the stinging/burning sensation during the application. The prototype pramoxine-benzalkonium chloride wipe produced significantly less stinging/burning than both 70% isopropyl alcohol and 3% hydrogen peroxide. Also, the prototype wipe did not produce more stinging and burning in superficial wounds compared to the saline control.

The effects of minoxidil, 1% pyrithione zinc and a combination of both on hair density: a randomized controlled trial.

BACKGROUND: Recent studies of antidandruff shampoos or tonics containing antifungal or antibacterial agents produced effects suggestive of a potential hair growth benefit. OBJECTIVES: The purpose of this 6-month, 200-patient, randomized, investigator-blinded, parallel-group clinical study was to assess the hair growth benefits of a 1% pyrithione zinc shampoo. The efficacy of a 1% pyrithione zinc shampoo (used daily), was compared with that of a 5% minoxidil topical solution (applied twice daily), a placebo shampoo and a combination of the 1% pyrithione zinc shampoo and the 5% minoxidil topical solution. METHODS: Two hundred healthy men between the ages of 18 and 49 years (inclusive) exhibiting Hamilton-Norwood type III vertex or type IV baldness were enrolled. Total hair counts, the primary efficacy measure, were obtained using fibre-optic microscopy and a computer-assisted, manual hair count method. Secondary measures of efficacy included assessments of hair diameter, as well as patient and investigator global assessments of improvement in hair growth. These were based on photographs of the scalp using both midline and vertex views. RESULTS: Hair count results showed a significant (P < 0.05) net increase in total visible hair counts for the 1% pyrithione zinc shampoo, the 5% minoxidil topical solution, and the combination treatment groups relative to the placebo shampoo after 9 weeks of treatment. The relative increase in hair count for the 1% pyrithione zinc shampoo was slightly less than half that for the minoxidil topical solution and was essentially maintained throughout the 26-week treatment period. No advantage was seen in using both the 5% minoxidil topical solution and the 1% pyrithione zinc shampoo. A small increase in hair diameter was observed for the minoxidil-containing treatment groups at week 17. Assessments of global improvements by the patients and investigator generally showed the benefit of 5% minoxidil. The benefit of the 1% pyrithione zinc shampoo used alone tended (P < 0.1) to be apparent only to the investigator. CONCLUSIONS: Hair count results show a modest and sustained improvement in hair growth with daily use of a 1% pyrithione zinc shampoo over a 26-week treatment period.

Comparison of the efficacy and safety of a combination topical gel formulation of benzoyl peroxide and clindamycin with benzoyl peroxide, clindamycin and vehicle gel in the treatments of acne vulgaris.

BACKGROUND: Topical clindamycin and benzoyl peroxide have each demonstrated clinical efficacy in the treatment of acne vulgaris. When used in combination, they promise greater efficacy than either individual agent used alone and the combined use of benzoyl peroxide with topical antibacterial has been shown to decrease the emergence of antibacterial resistant species. OBJECTIVE: The objective was to determine the efficacy and safety of a combination benzoyl peroxide plus clindamycin in a gel formulation compared with each of its 2 active constituents in gel vehicle, and gel vehicle given alone in the treatment of acne vulgaris. METHODS: In this 10-week, multicenter, double-blind trial, 480 patients with moderate to moderately severe acne were randomized to receive twice-daily treatment with 5% benzoyl peroxide plus 1% clindamycin, 5% benzoyl peroxide, 1% clindamycin, or vehicle. RESULTS: Significantly greater reductions in the number of inflammatory and total lesions were demonstrated in patients using combination therapy compared with those using any of its 3 individual components. Likewise, both physicians' and patients' global evaluations showed significantly greater improvements with the combination therapy than with its individual components. The most frequent adverse effect, dry skin, occurred to a similar extent in the combination and benzoyl peroxide treatment groups. CONCLUSION: The improved efficacy obtained with the combination therapy was accompanied by a tolerability profile similar to that of benzoyl peroxide alone, making this new combination product an alternative antimicrobial therapy for acne vulgaris.

A comparative trial of two retinoids commonly used in the treatment of acne vulgaris.

BACKGROUND: Topical retinoids are highly effective treatments for acne vulgaris. The various formulations and concentrations available allow physicians to tailor therapies to individual patient's needs and minimize the cutaneous irritation that is often observed with the use of these drugs. OBJECTIVE: To compare the efficacy and safety of tretinoin gel microsphere 0.1% with adapalene gel 0.1% in the treatment of acne vulgaris. METHODS: A 12-week double-blind study was conducted, and patients were evaluated at baseline and at weeks 2, 3, 4, 6, 8, 10, and 12. RESULTS: Although the two drugs displayed similar efficacy in the resolution of acne lesions at 12 weeks, a significantly greater reduction in the number of comedones was seen at week 4 among patients treated with tretinoin gel microsphere (p = 0.047). Patients receiving tretinoin gel microsphere had an increased incidence of dryness (weeks 8 and 10) and peeling (weeks 3, 6, 8, and 10) compared with those patients treated with adapalene gel, but the two groups were comparable with respect to erythema, burning/stinging, and itching. CONCLUSION: Both drugs have similar efficacy in the resolution of acne lesions but tretinoin gel microsphere may result in a faster onset of action in the reduction of comedones compared to adapalene.

A newly formulated topical triple-antibiotic ointment minimizes scarring.

A randomized study of polymyxin B sulfate-bacitracin zinc-neomycin sulfate versus simple gauze-type dressings in dermabrasion wounds assessed the effects that each treatment had on scarring. Each of three uniform dermabrasion wounds created on the upper backs of 70 subjects was treated concurrently with a triple-antibiotic ointment (polymyxin B-bacitracin-neomycin), a double antibiotic (polymyxin B-bacitracin), or a simple, non-occlusive, gauze-type dressing, twice daily for up to 14 days. Pigmentary changes and textural changes (scarring) appearing after healing at the skin surface test sites were compared to adjacent normal skin at 45 and 90 days post-dermabrasion. These changes were graded visually utilizing fluorescent light, long-wave ultraviolet light, and by clinical color photography. The triple-antibiotic ointment was superior to simple gauze-type dressing alone in minimizing the scarring observed in dermabrasion wounds. The benefit of this new ointment was more pronounced in its effect on pigmentary changes.

Irritation potential of a new topical tretinoin formulation and a commercially-available tretinoin formulation as measured by patch testing in human subjects.

BACKGROUND: A novel tretinoin preparation uses polyolprepolymer-2, a compound designed to reduce skin irritation by helping retain drugs on and in the surface layers of the skin. OBJECTIVE: We used patch testing to measure the effect of polyolprepolymer-2 on tretinoin-associated irritation. METHODS: Two patch test studies were conducted. The first assessed the effect of polyolprepolymer-2 by comparing commercially-available tretinoin formulations with respective polyolprepolymer-containing formulations of 0.025% tretinoin gel and 0.025%, 0.05%, and 0.1% tretinoin creams. The second assessed the effect of the polyolprepolymer-2 concentration on the potential decrease in irritation by comparing: (1) a commercially-available tretinoin cream with prototype tretinoin creams containing 20% polyolprepolymer-2 at three different concentrations of tretinoin (0.025%, 0.05%, and 0.1%); and (2) the effect of three different polyolprepolymer-2 concentrations (10%, 15%, and 20%) in prototype tretinoin creams on cumulative irritation. Patch agents were assigned to subjects according to a randomization schedule, and during a period of 5 days each subject received three 24-hour exposures to the test materials. Twenty-four hours elapsed between old patch removal and new patch application. RESULTS: In the first study, the tretinoin gel and cream containing polyolprepolymer-2 caused significantly less irritation than all equivalent formulations of the commercially-available tretinoin gel and creams except the 0.025% cream formulation. Irritation scores were not significantly different in terms of irritation in the 0.025% creams although scores did indicate a trend towards lower irritation with 0.025% tretinoin cream containing polyolprepolymer-2. In the second study, the tretinoin gel containing polyolprepolymer-2 and the three tretinoin prototype creams also containing polyolprepolymer-2 caused significantly less irritation than comparable concentrations of the commercially-available tretinoin. In addition, the 0.025% tretinoin gel formulation containing polyolprepolymer-2 was no more irritating than the commercially-available 0.025% tretinoin cream. CONCLUSION: Tretinoin formulations containing polyolprepolymer-2 are, in general, less irritating than the currently marketed tretinoin formulations.

Comparison of adapalene 0.1% solution and tretinoin 0.025% gel in the topical treatment of acne vulgaris.

A multicentre study was conducted to compare clinical safety and efficacy of adapalene 0.1% solution and tretinoin 0.025% gel, both topical treatments for acne, in a once-daily dosage regimen for 12 weeks. A total of 297 patients were enrolled by eight investigators in this randomized, investigator-masked study in a parallel group design. An open label period using adapalene followed this study to assess the long-term safety of adapalene solution. Adapalene and tretinoin proved to be clinically and statistically effective in treating acne by reducing inflammatory (47% and 50%, respectively) and non-inflammatory lesions (57% and 54%) as compared to baseline. When comparing patients who had 75% or greater improvement in open comedones, adapalene was shown to be significantly more effective than tretinoin. No serious adverse event was reported during this study, including during the long-term period. The reactions that occurred were similar between treatments, i.e. burning, pruritus, scaling, dryness and erythema.

Effects of stress inoculation training on athletes' postsurgical pain and rehabilitation after orthopedic injury.

The efficacy of a cognitive-behavioral intervention (stress inoculation training; SIT) for postsurgical anxiety, pain, and physical rehabilitation in injured athletes was tested. Sixty male athletes who underwent arthroscopic surgery for miniscus injury in 1 knee were randomly assigned to either treatment (SIT and physical therapy) or control (physical therapy only) conditions. Results showed that participants in the treatment group demonstrated significantly less postsurgical pain and anxiety during the rehabilitation process, compared with controls. Additionally, treated participants required fewer days to return to criterion physical functioning, compared with nontreated participants.

Noninvasive assessment of anesthetic activity of topical lidocaine formulations.

The effectiveness of a series of lidocaine formulations in producing anesthesia after topical application was evaluated in human volunteers. The formulations, five suspensions in 20% propylene glycol and one cream, were applied to the forearms for 3 h with occlusion with Hilltop chambers. Testing for anesthesia was performed electrometrically. All lidocaine-containing formulations produced significantly greater anesthesia than the blanks. The formulation containing tetradecyltrimethylammonium bromide produced greater anesthesia than that containing octadecyltrimethylammonium chloride. Changing the pH of the formulation from 7.9 to 10.0 had no significant effect. Other formulations (sodium lauryl sulfate and the cream) were no more effective than the plain formulation without surfactants. The rank order for the suspension formulations was the same as for steady-state permeation in in vitro experiments. However, application of the cream formulation produced greater effect in vivo than was anticipated from in vitro flux values.

Defining the susceptibility of acne-prone and sensitive skin populations to extrinsic factors.

Acne-Prone Skin. Acne-prone skin appears to be more susceptible to certain extrinsic factors that can either exacerbate existing disease or generate new lesions. Awareness of the factors that could worsen or interfere with therapy is important. In addition, identification of patients with minimal acne who are prone to outbreaks from extrinsic factors and provision of relevant advice could prove beneficial to significant numbers of patients. Sensitive Skin. From the perspective of our research, the definition of sensitive skin is still evolving. Certain individuals may view sensitive skin as fashionable; however, clinicians and the people who work in the personal-care industry know that when certain materials are applied to the skin, some individuals report symptoms (burning, stinging, itching, a tight feeling) and sometimes show traditional signs of irritation. The reasons for sensitive skin in these individuals may be obvious, but many times the complaints and signs of irritation occur in individuals who appear to be normal. Using our ongoing work we would like to suggest that the label "sensitive skin" apply to the following four categories: 1. Those individuals with obvious skin disease. 2. Those individuals with subclinical (mild) or atypical clinical signs of disease. 3. Those individuals who have experienced past insults to the skin. 4. Those individuals who do not fit into one of the above three categories and appear to be "normal". To define sensitive skin fully we may need to perform full profiles of the skin of these patients. In addition to history and examination, a battery of noninvasive tests may be helpful.(ABSTRACT TRUNCATED AT 250 WORDS)

Whirlpool folliculitis: a review of its cause, treatment, and prevention.

Folliculitis caused by Pseudomonas aeruginosa has been increasing due to the popularity of hot tubs, swimming pools, and whirlpools. The follicular pustules and inflammatory papules usually occur after an incubation period of two to four days and improve spontaneously in seven to ten days. Despite the discomforts of the condition, treatment is usually not necessary and may even prolong the infection. Since it is difficult to control the growth of Pseudomonas in hot tubs and whirlpools, attention to water conditions is the best way to prevent this irritating skin condition.

Locus of control and perceived alcohol ingestion in performance of a fine motor skill.

To investigate the influence of locus of control on a fine motor corrdination task where subjects had ingested or believed that they had ingested alcohol, 60 men who were enrolled in introductory psychology and scored in the upper or lower thirds of the population on Rotter's I-E Scale (30 external and 30 internal scorers) were randomly assigned to one of three treatment conditions: a control group (no alcohol expected/no alcohol received), an alcohol group (alcohol expected/alcohol received), and a placebo group (alcohol expected/no alcohol received). Pretest and posttest measures of performance on the Purdue Pegboard Test were obtained from all subjects. Subjects in the control groups were given three 6-oz. (177.4-ml) glasses of fruit punch over a 35-min. waiting period between pretest and posttest on the Purdue Pegboard. The alcohol groups drank a sufficient number of similar glasses (usually three) to produce a 0.1% measure on a breathalyzer before completing the posttest on the Purdue. Pegboard. The placebo groups were told that they were drinking an alcohol-based drink but were served three glasses of a nonalcoholic, rum-flavored fruit drink. These groups were also told that they measured 0.1% on a breathalyzer. Control groups, both internal and external scorers, showed essentially no change from pre- to posttest on the Purdue Pegboard. The alcohol groups, on the other hand, both internal and external scorers, showed a significant decrement in performance. The internal-placebo group did not differ from the two control groups and showed no decrement in performance.(ABSTRACT TRUNCATED AT 250 WORDS)

Erythema dyschromicum perstans and lichen planus: are they related?

A 53-year-old woman initially had lichen planus primarily on her extremities. Approximately 1 year later, lesions consistent with erythema dyschromicum perstans were observed. Both diseases cleared with griseofulvin therapy but returned after discontinuation of the drug. Retreatment with griseofulvin again resulted in clearing.

Differences that make a difference: comparisons of metacomponential functioning and knowledge base among groups of high and low IQ learning disabled, mildly mentally retarded, and normally achieving adults.

To determine if cognition among persons with learning disabilities (LD) and mild mental retardation (MMR) is similar, we compared metacomponential functioning and knowledge acquisition across groups of incarcerated adults with LD and high IQ (HIQLD), with LD and low IQ (LIQLD), with normal achievement (NA), and with MMR. The Slosson Intelligence Test Computer Report (Nicholson, 1984) formula established criteria for group inclusion. Metacomponential functioning among 77 males and 26 females was measured by a confidence test (Echternacht, Boldt, & Sellman, 1971) designed for the general knowledge subtest of the SRA Achievement Battery (Naslund, Thorpe, & Lefever, 1982). Knowledge base and group membership were significantly related to metacomponential ability (R2 = .84). Persons with HIQLD and LIQLD performed better than those with MMR on both measures. The HIQLD, however, did not outperform their peers with NA. Results show that (a) knowledge base is the best predictor of metacomponential skill, (b) metacomponential orchestration differentiates persons with HIQLD from those with LIQLD and both groups from persons with MMR, and (c) IQ mediates metacognition, but does not explain it. Education should emphasize knowledge acquisition for people with HIQLD; people with LIQLD and MMR require more attention to metacognition.

Fulminant transfusion-associated graft-versus-host disease in a premature infant.

A fatal case of transfusion-associated graft-versus-host disease developed in a premature infant after receiving several blood products, including nonirradiated white blood cells. Transfusion-associated graft-versus-host disease can be prevented. Irradiation of blood products is the least controversial and most effective method. Treatment was unsuccessful in most reported cases of transfusion-associated graft-versus-host disease. Therefore irradiation of blood products before transfusing to patients susceptible to transfusion-associated graft-versus-host disease is strongly recommended.