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A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients.

Merchant TE, Bosley C, Smith J, Baratti P, Pritchard D, Davis T, Li C, Xiong X - Radiat Oncol (2007)

Bottom Line: Significant differences in specific variables favoring APP cream use were noted in some patients including skin comfort variables, dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), smooth (p = 0.012) and dermatologic variables, dryness (p = 0.013), erythema (p = 0.002) and peely (p = 0.008).Grouped CTC scores were supportive of APP cream (p = 0.004).In comparing the first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Radiological Sciences, St. Jude Children's Research Hospital, Memphis, TN, USA. thomas.merchant@stjude.org

ABSTRACT

Purpose: Radiation dermatitis is a common side effect of radiation therapy (RT). In severe cases, RT must be interrupted until the skin heals, which can compromise treatment. The purpose of the study was to compare an anionic polar phospholipid (APP)-based cream and an aloe vera-based gel to determine their effectiveness in preventing and treating radiation dermatitis.

Patients and methods: Forty-five pediatric patients (median age, 11 years) with various diagnoses who received at least 23.4 Gy participated. APP cream and aloe vera gel were symmetrically applied within the irradiated field after each treatment. Three measures were collected before, during and after completion of treatment: subject's skin comfort, dermatologic assessment, and common toxicity criteria (CTC).

Results: Significant differences in specific variables favoring APP cream use were noted in some patients including skin comfort variables, dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), smooth (p = 0.012) and dermatologic variables, dryness (p = 0.013), erythema (p = 0.002) and peely (p = 0.008). Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing the first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream.

Conclusion: APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.

No MeSH data available.


Related in: MedlinePlus

Study Questionnaires. The Subject Skin Condition Assessment form (A) and Dermatologic Assessment form (B) are presented.
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Figure 1: Study Questionnaires. The Subject Skin Condition Assessment form (A) and Dermatologic Assessment form (B) are presented.

Mentions: The subject skin comfort assessment was completed by the patient or a parent. The assessment consisted of 15 items (variables), each on a 4-level scale (Figure 1). This assessment included both positive items (e.g., "soft" and "feels good") and negative items (e.g., "itch" and "dry"). The dermatologic assessment (Figure 1), which was completed by the nursing staff, was a similar questionnaire but consisted of negative items only (e.g., "dryness" and "erythema"). The CTC for adverse events involving the skin was as follows: grade 1 – none or no change; grade 2 – scattered macular or papular eruption or erythema that is asymptomatic; grade 3 – scattered macular or papular eruption or erythema with pruritis or other associated symptoms; grade 4-generalized symptomatic macular, popular, or vesicular eruption; grade 5 – exfoliative dermatitis or ulcerating dermatitis.


A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients.

Merchant TE, Bosley C, Smith J, Baratti P, Pritchard D, Davis T, Li C, Xiong X - Radiat Oncol (2007)

Study Questionnaires. The Subject Skin Condition Assessment form (A) and Dermatologic Assessment form (B) are presented.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2238757&req=5

Figure 1: Study Questionnaires. The Subject Skin Condition Assessment form (A) and Dermatologic Assessment form (B) are presented.
Mentions: The subject skin comfort assessment was completed by the patient or a parent. The assessment consisted of 15 items (variables), each on a 4-level scale (Figure 1). This assessment included both positive items (e.g., "soft" and "feels good") and negative items (e.g., "itch" and "dry"). The dermatologic assessment (Figure 1), which was completed by the nursing staff, was a similar questionnaire but consisted of negative items only (e.g., "dryness" and "erythema"). The CTC for adverse events involving the skin was as follows: grade 1 – none or no change; grade 2 – scattered macular or papular eruption or erythema that is asymptomatic; grade 3 – scattered macular or papular eruption or erythema with pruritis or other associated symptoms; grade 4-generalized symptomatic macular, popular, or vesicular eruption; grade 5 – exfoliative dermatitis or ulcerating dermatitis.

Bottom Line: Significant differences in specific variables favoring APP cream use were noted in some patients including skin comfort variables, dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), smooth (p = 0.012) and dermatologic variables, dryness (p = 0.013), erythema (p = 0.002) and peely (p = 0.008).Grouped CTC scores were supportive of APP cream (p = 0.004).In comparing the first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Radiological Sciences, St. Jude Children's Research Hospital, Memphis, TN, USA. thomas.merchant@stjude.org

ABSTRACT

Purpose: Radiation dermatitis is a common side effect of radiation therapy (RT). In severe cases, RT must be interrupted until the skin heals, which can compromise treatment. The purpose of the study was to compare an anionic polar phospholipid (APP)-based cream and an aloe vera-based gel to determine their effectiveness in preventing and treating radiation dermatitis.

Patients and methods: Forty-five pediatric patients (median age, 11 years) with various diagnoses who received at least 23.4 Gy participated. APP cream and aloe vera gel were symmetrically applied within the irradiated field after each treatment. Three measures were collected before, during and after completion of treatment: subject's skin comfort, dermatologic assessment, and common toxicity criteria (CTC).

Results: Significant differences in specific variables favoring APP cream use were noted in some patients including skin comfort variables, dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), smooth (p = 0.012) and dermatologic variables, dryness (p = 0.013), erythema (p = 0.002) and peely (p = 0.008). Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing the first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream.

Conclusion: APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.

No MeSH data available.


Related in: MedlinePlus