Clinical Studies

PlastReconstr Surg. 2010 Aug;126(2):524-31.

Topical silicone gel versus placebo in promoting the maturation of burn scars: a randomized controlled trial.

van der Wal MB, van Zuijlen PP, van de Ven P, Middelkoop E.
Burn Center and the Department of Plastic, Reconstructive, and Hand Surgery, Red Cross Hospital, Beverwijk, The Netherlands.
Abstract
BACKGROUND: Silicone sheets are widely used in the treatment of hypertrophic scars, although application around joints may cause limited adherence and reduced movement. To approach these problems, a topical silicone gel was developed that can be applied easily in a thin layer, and that is nonrestrictive and less apparent. The objective of this study was to investigate the effectiveness of topical silicone gel in promoting the maturation of burn scars.
METHODS: Forty-six scars on 23 patients were included in a randomized, placebo-controlled, within-subject comparative, double-blinded, clinical trial and followed for 1 year. The mean age of the scars at inclusion was 4 months. Effectiveness on scar quality was evaluated using the Patient and Observer Scar Assessment Scale and the DermaSpectrometer. Significance was tested using repeated measures analyses and Wilcoxon paired-sample signed rank tests.
RESULTS: Over all visits, the benefit on surface roughness was statistically significant (p = 0.012). At individual time points, the surface of the topical silicone gel-treated scars showed significantly less roughness (p = 0.014) at 3 months after start of the treatment, and the topical silicone gel-treated scars were significantly less itchy (p = 0.018 and p = 0.013, respectively) at 3 and 6 months.
CONCLUSION: Topical silicone gel significantly improves the surface roughness of burn scars, and patients experience significantly less itching in the first half year after application.

ClinExpRheumatol. 2009 May-Jun;27(3 Suppl 54):51-4.

Vitamin E gel reduces time of healing of digital ulcers in systemic sclerosis.

Fiori G, Galluccio F, Braschi F, Amanzi L, Miniati I, Conforti ML, Del Rosso A, GeneriniS,Candelieri A, Magonio A, Goretti R, Rasero L, Matucci-Cerinic M.
Department of Biomedicine, Scleroderma Ulcer Care Unit, Division of Rheumatology, AOUC, University of Florence, Italy.
Abstract
BACKGROUND: In systemic sclerosis (SSc), digital ulcers (DU) are painful, difficult to heal and frequently infected, thus greatly affecting quality of life and increasing SSc-related disability. Vitamin E has been previously used in cutaneous lesions for its antioxidant and anti-inflammatory effects.
OBJECTIVES: To study the healing effect of D-alpha-tocopheryl acetate (acetic ester of alpha-tocopherol) (VE) gel on DU of SSc patients.
METHODS: 27 SSc patients with a total of 86 DU were enrolled in an open pilot study. The patients were randomly assigned to two groups: 15 patients were treated until DU healing with the local standard ulcer care protocol with the application of vitamin E gel (experimental group), while 12 patients were treated with standard ulcer care protocol only (control group). In both groups, DU were treated twice a week and pain was scored by a NRS (numeric rating scale). In both groups the cost of medications was analysed.
RESULTS: VE induced a faster healing of DU in respect to controls (13.22+/-2.72 weeks, versus 20.94+/-3.65; p<0.0001) with a lower number of medications (26.18+/-5.63 vs. 41.88+/-7.31; p<0.0001). Resolution of pain was faster in experimental (17.82+/-4,59 medications) than in controls (26.26+/-19.16 medications) (p=0.0022). In the experimental group, the cost of medications was significantly lower (6,919.15 euros/patient) than in the control group (11,056.32 euros/patient).
CONCLUSION: The application of VE reduces time of healing and has a faster resolution of pain, with a significant reduction of costs. Topical VE may improve the management of DU in SSc.

Br J Dermatol. 2010 Sep;163(3):557-63. doi: 10.1111/j.1365-2133.2010.09813.x.
 

Accelerated resolution of laser-induced bruising with topical 20% arnica: a rater-blinded randomized controlled trial.

Leu S, Havey J, White LE, Martin N, Yoo SS, Rademaker AW, Alam M.
Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.
Abstract
BACKGROUND: Dermatological procedures can result in disfiguring bruises that resolve slowly.
OBJECTIVES: To assess the comparative utility of topical formulations in hastening the resolution of skin bruising.
METHODS: Healthy volunteers, age range 21-65 years, were enrolled for this double (patient and rater) blinded randomized controlled trial. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser (Vbeam; Candela Corp., Wayland, MA, U.S.A.). Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0·3% retinol, 20% arnica, or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist not involved with subject assignment rated bruises [visual analogue scale, 0 (least)-10 (most)] in standardized photographs immediately after bruise creation and at week 2.
RESULTS: There was significant difference in the change in the rater bruising score associated with the four treatments (anova, P=0·016). Pairwise comparisons indicated that the mean improvement associated with 20% arnica was greater than with white petrolatum (P=0·003), and the improvement with arnica was greater than with the mixture of 1% vitamin K and 0·3% retinol (P=0·01). Improvement with arnica was not greater than with 5% vitamin K cream, however.
CONCLUSIONS: Topical 20% arnica ointment may be able to reduce bruising more effectively than placebo and more effectively than low-concentration vitamin K formulations, such as 1% vitamin K with 0·3% retinol.
© 2010 The Authors.Journal Compilation © 2010 British Association of Dermatologists.
PMID: 20412090 [PubMed - indexed for MEDLINE]

J Nat Med. 2011 Apr;65(2):330-5. Epub 2011 Jan 22.
 

Evaluation of anti-inflammatory and antinociceptive effects of D-002 (beeswax alcohols).

Ravelo Y, Molina V, Carbajal D, Fernández L, Fernández JC, Arruzazabala ML, Más R.
Pharmacology Department, Centre of Natural Products, National Centre for Scientific Research, 198 Ave Between 19 and 21 sts.,Atabey, Playa, Havana, Cuba.
Abstract
D-002, a mixture of six higher aliphatic alcohols purified from beeswax, displayed anti-inflammatory effects in carrageenan-induced pleurisy and cotton pellet granuloma in rats. The aim of the present study was to confirm the anti-inflammatory properties of D-002 and to explore its potential analgesic effects. Xylene-induced mouse ear oedema was used to assess the anti-inflammatory effect, acetic acid-induced writhing and hot plate responses for the analgesic activity, and the open field and horizontal rotarod tests for motor performance. For anti-inflammatory tests, mice were randomised into a negative vehicle control and five xylene-treated groups: the vehicle, D-002 (25, 50 and 200 mg/kg) and indomethacin 1 mg/kg (reference drug). Treatments were given for 15 days. Effects on oedema formation and myeloperoxidase (MPO) activity were tested. For analgesia and motor performance tests, mice were randomised into a vehicle control and D-002-treated groups (25, 50 and 200 mg/kg). Two sets of experiments were done, which included acute and repeat (15 days) dosing. D-002 (25, 50 and 200 mg/kg) significantly decreased xylene-induced ear oedema (44.7, 60.8 and 76.4%, respectively) and the increase of MPO activity induced by xylene (38.0, 47.0 and 57.0%, respectively), while indomethacin significantly inhibited xylene-induced oedema (59.9%) and MPO activity (57.5%). Single and repeat doses of D-002 (25, 50 and 200 mg/kg) decreased the acetic acid-induced writhing responses by 21.2, 28.2 and 40.1%, for the single doses; 25.2, 35.1 and 43.2%, respectively, for the repeat doses, but did not affect the hot plate, open field and rotarodbehaviours. Aspirin 100 mg/kg significantly decreased acetic acid-induced abdominal constrictions and morphine (5 mg/kg) significantly increased the latency of the hot plate response. This study confirmed the anti-inflammatory effects of D-002 and demonstrated its analgesic effects on the acetic acid-induced writhing, but not on the hot plate response, which suggests that the antinociceptive effects of D-002 could be related to its anti-inflammatory activity.