Efficacy of Early Initiation of a Gel Containing Extractum Cepae, Heparin, and Allantoin for Scar Treatment: An Observational, Noninterventional Study of Daily Practice

January 2013 | Volume 12 | Issue 1 | Original Article | 38 | Copyright © January 2013

Gunter H. Willital MDa and Jeannette Simon MDb

aPediatric Surgical Research Institute Münster-Datteln, Münster, Germany bMerz Pharmaceuticals GmbH, Frankfurt, Germany

quently used for treatment of scars. While the efficacy of many topical scar treatments is yet to be established in robust, prospective clinical trials,8 Contractubex® (Merz Pharmaceuticals GmbH, Frankfurt, Germany), a preparation containing extractum cepae, heparin, and allantoin, has demonstrated efficacy in scar improvement in a number of randomized controlled trials.9,10
The aim of this study was to investigate the efficacy of the scar gel containing extractum cepae, heparin, and allantoin in improving scar appearance, size, and skin sensation when treatment was initiated early in a large cohort of patients treated in routine clinical practice.


This observational, noninterventional study included 1,268 patients treated by physicians from a range of disciplines: general practitioners, surgeons, gynecologists, and dermatologists. Patients 6 years and older with skin lesions were eligible for inclusion into the study. The study was performed during routine clinical treatment, with observations made and findings recorded at 3 examination appointments over a period of 4 to 5 months. Patients with a known allergy or sensitivity to skin-care products were excluded from the study, as were those with acute or chronic skin diseases (such as atopic dermatitis and atopic eczema), unless the scar area was unaffected by the disease.
Dosage and Period of Observation
Contractubex, a scar gel containing extractum cepae, heparin, and allantoin, was applied twice daily in accordance with the manufacturer’s instructions. Patients were assessed when treatment was initiated (visit 1), with subsequent assessments after 2 to 3 months of treatment (visit 2), and at the end of the study after 4 to 5 months of treatment (visit 3). Treatment records were kept for all 3 visits.
Observational Parameters
At each visit, the treating physician evaluated the extent of scar formation with regard to pliability (consistency/hardness), color (redness), sensation, and size. Pliability was rated as one of the following: normal skin, slightly hardened, or markedly hardened. Color was rated as pale/skin-colored, slightly red, or markedly red. Skin sensation with respect to pain, tension, and pruritus could be rated as sensitive to pain, tight, or itchy. At visit 2, patients were asked to provide subjective ratings of the properties of the medication in terms of smell (pleasant, neutral, or unpleasant), spreadability (very good, moderate, or bad), absorption (rapidly absorbed, is absorbed, or is absorbed slowly), and skin sensation after application (improved, unchanged, or worse). Efficacy and tolerability of the treatment were rated at visits 2 and 3 by both the physician and the patient using a 4-point scale (4 = very good, 3 = good, 2 = moderate, 1 = poor). Any adverse drug reactions were also recorded.
Results for color, pliability, sensation of pain, tension, and pruritus at both visits 2 and 3 were analyzed in comparison with those obtained at visit 1, using the McNemar 2-sided test.


Patient Demographics and Characteristics

In total, 1,268 patients were included in the study. Of these, 825 (65.1%) were female and 443 (34.9%) were male. The average age of the patients was 41 years.
Most patients had received injuries on the upper body (34.5%), followed by the extremities (32.2%) and other sites, including the head and neck (17.4%) and the face (10.8%). Surgical wounds (65.9%) were by far the most common cause of injury; other causes included cuts and abrasion wounds (18.8%), burns and scalds (7.4%), acne (4.6%), and cosmetic interventions (1.6%). The majority of injuries (56.2%) were less than 3 weeks old when treatment was initiated.
Twenty percent of patients had received wound/scar treatment before the study, consisting primarily of preparations containing iodine (12.1%), dexpanthenol (11.1%), antibiotics (10.7%), or cortisone (7.1%). Surgical revision had been carried out in at least 5% of cases. However, in 77.4% of patients, treatment with the scar gel containing extractum cepae, heparin, and allantoin was the first medication received for the lesion. In 2.6% of cases, no pretreatment information was available. In 28.5% of cases, delayed wound healing was recorded.
Scar Color and Pliability
Figure 1 shows the assessment of scar color (redness) and pliability (consistency/hardness) at each visit. At visit 2, there was a statistically significant improvement in both scar color and pliability compared with visit 1 (P<.0001 for both parameters); a further improvement was seen at visit 3, which was also significant compared with visit 1 (P<.0001 for both parameters). At treatment initiation (visit 1), 45.7% of lesions were rated as markedly red and 32.2% as markedly hardened, but at visit 2, the percentage of scars rated as markedly red had decreased to 3.6% and those rated as markedly hardened had decreased to 4.7%. By the end of the observation period (visit 3), there had been a further improvement, with only 1% of scars being classified as markedly red and 0.9% of scars being classified as markedly hard (Figure 1). In addition, 56.9% of scars had a normal consistency and 67.3% were similar in color to that of normal, healthy skin by the end of the observation period.
Scar Size
Reductions in both scar width and scar height, from visit 1 to visit 3, could be demonstrated in this study. Specifically, mean scar width decreased by 31.5% (from 8.9 mm to 6.1 mm), and mean scar height diminished by 47.8% (from 2.3 mm to 1.2 mm) (Figure 2).