Bepanthen - Topical

Bepanthen - Topical

PEP Topic 
Radiodermatitis
Description 

Bepanthen is an antiseptic cream that contains Vitamin B5 and almond oil. The combination of ingredients has properties as a disinfectant, emollient, and supportive agent for cell metabolism. Bepanthen cream was evaluated in patients with cancer for prevention and treatment of radiodermatitis.


 

Effectiveness Not Established

Research Evidence Summaries

Lokkevik, E., Skovlund, E., Reitan, J.B., Hannisdal, E., & Tanum, G. (1996). Skin treatment with Bepanthen cream versus no cream during radiotherapy. Acta Oncologica, 35, 1021–1026.

doi: dx.doi.org/10.3109/02841869609100721
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Study Purpose:

To compare Bepanthen cream with no topical ointment

Intervention Characteristics/Basic Study Process:

Patients used Bepanthen on one side of the treatment field and used no topical treatment on the other side. Patients were instructed to not inform the physician of which region or field received the application of the cream, and they randomized their own application. Bepanthen twice a day began on day 1 of radiation therapy. Skin assessments were performed weekly during treatment and two weeks following treatment.
 

Sample Characteristics:

  • The study sample (N = 79) was comprised of patients with breast (n = 63) and T1 and T2 N0, M0 laryngeal (n = 16) cancer.
  • Median age of patients with breast cancer was 55 years, with a range of 31–78 years. Median age of patients with laryngeal cancer was 69 years, with a range of 51–85 years.
  • Patients with laryngeal cancer received definitive radiation therapy at 2 Gy/fraction and total dose of 70 Gy.
  • Twenty-one patients with breast cancer received low-dose cyclophosphamide, methotrexate, and 5-fluorouracil during radiation therapy at cobalt-60 and total dose of 50 Gy.


 

Study Design:

The study used a quasi-experimental blinded trial design.

Measurement Instruments/Methods:

  • The European Oncology Radiation Therapy Consortium and Radiation Therapy Oncology Group acute skin reaction scoring was recorded weekly, two, and six to eight weeks following treatment.
  • Erythema was chosen as the primary efficacy variable.
  • Wilcoxan-Signed Rank-Test was used for the primary and secondary efficacy variables.
  • Logistic regression analysis was performed to examine the effect of concomitant chemotherapy, skin type, gender, age, and upper verses lower area (for patients with breast cancer only).

 

Results:

For both cancers, all skin reactions were more severe at completion of six weeks of radiation treatments, which was chosen as a reference point to standardize assessment data. No significant difference was observed in erythema, most desquamation, itch, or pain. No significant effect of any of the variables was found in regression analysis regarding erythema and desquamation.
 

Conclusions:

Bepanthen did not provide any significant benefit.

Limitations:

  • In patients with breast cancer, there were many different techniques of radiation therapy administration and use of bolus.
  • No information about patient adherence to the protocol was provided.
  • The two groups of cancers treated received different accumulative doses of irradiation.
  • Data was not separated for those who also received chemotherapy, which would affect skin toxicity.

Nursing Implications:

Tissue toxicity is associated with 60-cobalt.

Roper, B., Kaisig, D., Auer, F., Mergen, E., & Molls, M. (2004). Theta-cream versus bepanthol lotion in breast cancer patients under radiotherapy. Strahlentherapie und Oncologie, 180, 315–322.

doi: 10.1007/s00066-004-1174-9
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Study Purpose:

To compare Theta-cream with standard skin care using Bepanthol (Bepanthen) lotion to prevent acute radiation side effects in skin tissue

 

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to use Theta-Cream or Bepanthol lotion during radiation therapy. Medication was applied lightly to the treatment field twice daily, starting within one week before beginning radiation therapy. Patients requested to wash irradiated skin gently with care to skin marks. No other prophylactic topical treatment was allowed.

Sample Characteristics:

  • The study sample (N = 20) was comprised of female patients with early-stage breast cancer.
  • Mean age was 56 years for the Theta-Cream group and 52 years for the Bepanthol lotion group, with a range of 43–65 and 38–61 years, respectively. 

Study Design:

The study used a randomized controlled blinded trial design.

Measurement Instruments/Methods:

  • All patients had thermoluminescent dosimeter (TLD) measurements of actual dose delivered to skin surface once during their radiation series.
  • At 0, 30, and 50 Gy, acute skin toxicity was scored with modified Radiation Therapy Oncology Group (RTOG) scoring; RTOG scoring was modified for further discrimination of low scores.
  • Erythema, desquamation, and efflorescence were judged by inspection; elevation of skin temperature in comparison with the contralateral breast by palpation; and itchiness according to patients’ statements.
  • Skin toxicity was scored separately for three localizations. The maximal score was recorded and median values were compared between the two groups.
  • Patients were asked for subjective content with their skincare regimen and if they would recommend it for other patients using a visual analog scale.

Results:

At 50 Gy, there was a insignificant trend in favor of Bepanthol lotion with a median total score of 8 (range 3–14) versus 11 (range 3–15) with Theta-Cream. There was no difference for maximal scores in every single aspect of skin toxicity for both groups at 30 Gy.

Conclusions:

In direct comparison with dexpanthenol-containing lotion, no advantage for Theta-Cream was found. There were no differences in skin toxicity between groups using Theta-Cream or Bepanthen.

Limitations:

  • The study had a small sample size, with less than 50 patients.
  • Patients in the Theta-Cream group were slightly older and more often had ongoing hormonal treatment.
  • Validity and reliability of modified RTOG scoring system was not discussed.
  • Article states random assignment, but study plan states patients were alternately assigned into two groups.

Schmuth, M., Wimmer, M.A., Hofer, S., Sztankay, A., Weinlich, G., Linder, D.M., . . . Fritsch, E. (2002). Topical corticosteroid therapy for acute radiation dermatitis: A prospective, randomized, double-blind study. British Journal of Dermatology, 146, 983–991.

doi: 10.1046/j.1365-2133.2002.04751.x
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Study Purpose:

To compare treatment with topical 0%–1% methylprednisolone versus 0%–5% dexpanthenol and historical controls in a cohort of patients undergoing fractionated radiation therapy

Intervention Characteristics/Basic Study Process:

After obtaining baseline data on an initial control cohort of untreated patients (n = 15), a subsequent cohort of patients was randomized to either 0%–1% methylprednisolone aceponate cream or 0%–5% dexpanthenol cream. Patients were instructed to apply the assigned cream twice daily from initiation of radiation therapy and for a two-week period after completion. No other topical medications, emollients, or powders were used during this period.

Sample Characteristics:

  • The study sample was comprised of historical controls as well as patients using methylprednisolone aceponate cream (n = 10) and patients using dexpanthenol (n = 11).
  • Mean age of the methylprednisolone group, dexpanthenol group, and historical controls was 62, 44, and 55 years, respectively, with a range of 39–75 years, 35–74 years, and 29–75 years, respectively.
  • All patients were women with breast cancer.

Setting:

The study took place at the University of Innsbruck in Austria.

Study Design:

The study used a prospective randomized double-blind study design with comparison to historical controls.

Measurement Instruments/Methods:

  • Patients were assessed immediately prior to initiation of radiation therapy and weekly thereafter or erythema, desquamation, erosion, induration, and hyperpigmentation on a four-point scale: none (0) to severe (3). The total clinical score was a sum of individual ratings.
  • To assess the impact of radiation therapy on epidermal barrier function, transepidermal water loss was measured weekly over four different areas within the irradiated field (one test per quadrant) and over one control area on the volar forearm using an evaporimeter.
  • Recordings were not taken over skin showing extensive erosions.
  • Quality of life was measured at the beginning of radiation therapy and after completion of the follow-up period to evaluate skin-specific (Skindex) and general outcome measures (SF-36).

Results:

Comparison of treatment groups with the historical, untreated control group suggested that either of the two topical regimens was superior to no treatment with respect to transepidermal water loss measurements, but not statistically significant. Transepidermal water loss levels did not differ between patients who received adjuvant chemotherapy and those who did not. There were no differences in quality-of-life findings. No quality-of-life data were obtained from untreated individuals in the preliminary cohort group. Skindex scores showed appearance of radiation dermatitis in virtually all participants. The dexpanthenol group showed deterioration that reached statistical significance for dimensions of depression, embarrassment, discomfort, and limitations (p < 0.05).

Conclusions:

Prophylactic and ongoing use of topical therapy with topical corticosteroid or dexpanthenol-containing emollient does not prevent radiation dermatitis.

Limitations:

  • The study sample was small.
  • The 36-SF has been used to assess qualityo f life in patients with acne and psoriasis but not patients with radiation dermatitis.
  • Skindex has been used to assess quality of life in a variety of dermatologic conditions, but not specifically used for radiation dermatitis.
  • Median age of patients vary by 18 years, with an older median in methylprednisolone group.
  • Scale for dermatitis grading is difficult to compare to standard scales used for radiation therapy-induced dermatitis.

Schreck, U., Pausen, F., Bamberg, M., & Budach, W. (2002). Intraindividual comparison of two different skin care conceptions in patients undergoing radiotherapy of the head-and-neck region: Creme or powder? Strahentherapie und Onkologie, 178, 321–329.

doi: dx.doi.org/10.1007/s00066-002-0912-0
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Study Purpose:

To assess differences between skin care with cream or powder formulations and protocols during radiation therapy

Intervention Characteristics/Basic Study Process:

Twelve patients receiving radiation therapy to the head and neck region were randomly assigned to treat one side of the neck with cream and the contralateral side with powder. Highly detailed treatment regimens were defined, including cleaning and care for each type of skin problem that might be encountered. Care included a variety of topical treatments and dressings. All wound dressings and visible cream were removed before each radiation therapy session.

Sample Characteristics:

  • The study sample (N = 12) was comprised of patients with cancer of the head and neck region.
  • Eleven patients received adjuvant radiation therapy; eight patients received conventional fractionated radiation therapy up to  60 Gy, 2 up to 50, and all received 50–72 Gy.

Setting:

The study took place at the University of Tuebingen in Germany.

Study Design:

The study used a quasi-experimental design.

Measurement Instruments/Methods:

  • Objective and subjective assessment and photo documentation were performed at therapy onset and weekly during therapy.
  • Skin dermatitis was scored weekly beginning with onset of therapy using a standard form based on skin toxicity scales.
  • Patient questionnaires scored feeling of local warmth, tension, itch, pain, and general discomfort on a four-point scale
  • Patient preference was considered.

Results:

Because of the small sample size, analysis was limited to description. No relevant differences were observed between the two treatment options according to the objective and subjective assessment criteria.

Conclusions:

Onset and degree of acute skin reactions and differences in symptom relief between the two treatments could not be demonstrated.

Limitations:

  • The sample size was small, with less than 30 participants.
  • The trial was not strictly comparing cream and powder treatments (moist desquamation provided for dressings on the cream side and methyl violet solution and Bepanthen cream on the powder side). Complex protocol defined with use of many different treatments further complicates ability to draw any conclusions in the study.
  • Validity and reliability of patient scoring was not noted.

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