The Nutrition & Hygiene Company

MEDICAL UPDATES

VOL. 1 Series No. MU005-2011

A Randomized Controlled Trial On The Efficacy Of Zinc Oxide Versus Zinc Oxide With Allantoin In The Treatment Of Irritant Contact Diaper Dermatitis

Hazel A. Villaluz,MD, Ma. Lucila M. Perez MD, Nepthalie R. Ordonez MD, Lourdes L. Balcueva MD, Department of Pediatrics-2002

 

ABSTRACT

BACKGROUND: Diaper dermatitis is the most common dermatologic disorder of infancy, with 7 to 35% of infants in diapers affected1, with the highest prevalence occurring between 9 to 12 months of age⁹. It accounts for about 97 doctor visits per 1000 infants in 0-2 years of age group, according to National Survey of Medicine 13, and Pediatricians provide 75% if services for the treatment.3

   

It is condition caused by the combination of wearing diapers, and incontinence of urine and feces. The available evidence suggests that maceration of the stratum corneum by the water increases susceptibility to frictional damage, and epidermal permeation of irritants.2 Other risk factors identified are: nutritional factor and diaper factor.

   

Breastfeed infants have less frequent diaper rash than those who are bottle fed. Solid foods decreases stool frequency, thus decreasing frequency of diaper eruptions.

 

Protecting the skin in the diaper area is of great benefit in all forms of diaper dermatitis. Advances in different aspects of technology have been directed towards the prevention and treatment of diaper dermatitis. Pharmaceuticals have designed diapers that deliver dermatological formulations to help protect skin from over hydration and irritation.

 

Zinc oxide pastes are excellent in preventing diaper dermatitis. Some pharmaceuticals have added substances like allantoin to the usual zinc oxide paste to hasten its effect. Allantoin is said to be proliferant, an epithelialisation stimulant, and a chemical debrider. It is used  in skin cosmetics, as well as in other products like shampoo, lotion, etch.

 

Many topical agents were made available to the market for treatment of the skin lesions. It would very helpful for the physicians to know if the new topical agents will be comparable if not more effective than the most frequently used ones today.

 

OBJECTIVE: To compare the efficacy of Zinc Oxide combined with Allantoin against pure Zinc Oxide for the treatment of uncomplicated diaper dermatitis among infants.

 

STUDY DESIGN AND SETTING: Randomized Double Blind Controlled Clinical Trial in a tertiary private hospital.

 

SUBJECTS: Patients admitted at MCU Department of Pediatrics and those seen as outpatient whose ages ranges from 0-24 months old diagnosed with uncomplicated diaper dermatitis (absence of violaceous plaque and nodules as seen in granuloma gluteale infantum; without fungal invasion).

 

METHODOLOGY: Patients who had eruptions in the diaper area were recruited and were classified according to severity: mild diaper dermatitis – with erythematous macules and patches with or without scales; moderate DD – with erythematous patches with micropapules and superficial macerations and severe DD – erythematous patches with erosions or ulcers that are well demarcated and punched out with slightly elevated borders.

 

All patients eligible for the study had KOH examinations of the skin at the diaper area to note for the presence of any spores or hyphae indicating the presence of fungi. The swabbing was done by principal investigator and the KOH examinations were done by the medical technologist. Those who are KOH (+) were excluded and those were KOH (-) were included. Parental informed consent were obtained.

 

Data in the history such as sex, age, and with or without diarrhea, the duration of the diaper dermatitis, and the character of rash were described. Diapering strategies as to the type of diaper used and frequency in the change of the diaper were noted. Maternal factors  such as maternal age, educational attainment, etch were also documented.

 

Randomization using the table of random numbers was done with the help of another individual who was also the one who distributed the products to be tested.

  

Subjects and the physician observer were not aware of the product being tested as well as the group assignment. The products have the same color (white), odor (baby powder), and consistency (talc based). They were packed by the drug company, in the same manner and packaging. However, a coded identification of each product were kept by the drug company, with their corresponding number. Patients were taught to apply the products, about 1/2 inch, ever after each diaper change, at least 3 times a day.

 

Those patients seen at the OPD were ask to follow up every two (2) days for reassessment. Patients admitted were also assessed every two days by a blinded observer up to the end of the study. Subjects had their addresses taken and those who were unable to comeback were visited at home for evaluation.

 

The number of days by which complete resolution or disappearance of the rash occurred were recorded. Monitoring of

the patients were stopped when complete resolution were recorded as no response or with partial response accordingly. Those who did not respond will had a repeat KOH examination. They were evaluated to determine the possible cause of non-response. Any adverse reaction were also noted and recorded.

 

STATISTICAL ANALYSIS:  Baseline Characteristics Analysis:

Sex distribution, mean age of the respondents, type of diapering strategies, character of the rashes, mean days of illness, and presence

of diarrhea were subsequently analyzed using the chi square test, and the level of significance is P=0.05.

 

Efficacy of Treatment:

The duration of treatment was analyzed using mean and ± ISD, and the groups were compared using t-test. The response

to treatment were analyzed using the number and percentages with complete response, partial response and no response, and were compared using the chi square set.

 

RESULTS: From April 2002 to June 2002, 38 subjects were enrolled in the study. They were distributed equally into two groups. Zinc oxide and the Zinc Oxide with Allantoin, after randomization. The age distribution ranged from less than 30 days to 18 months. Comparison of the two groups according to age showed mean ages of 5.76 ± 5.08 for Zinc Oxide group and 5.13 ± 4.32 for Zinc Oxide with Allantoin group. Slightly more patients without diarrhea were seen in both groups. (Zinc Oxide = 53%, Zinc Oxide + Allantoin = 58%). More patients in the Zinc Oxide group used both cloth and disposables (53%) while in the Zinc Oxide with Allantoin group, more patients (53%) used disposable diapers alone. Diaper change is noteworthy for they change every time diaper is wet with 79% for Zinc Oxide and 74% for Zinc Oxide with Allantoin. All subjects were applied to the topical agent assigned to them at least 3 times a day. Number of applications were more than 3 times with 68% for Zinc Oxide and 32% for the Zinc Oxide with Allantoin. Majority of the mothers finished high school, and belong to the 22 to 26 years age group with mean of 21.11 ± 3.03 for Zinc Oxide group and 22.95 ± 3.56 for the Zinc Oxide with Allantoin group. Comparison of the two groups showed comparable maternal characteristics. With the severity of rash, the mild form was exhibited in 53% for the Zinc Oxide with Allantoin while the Zinc Oxide had a 68% for the moderate. Mean size of lesion for Zinc Oxide was comparable with that of Zinc Oxide with Allantoin. The duration of dermatitis is at 3.13 ± 1.5 days in both groups. Therapeutic response after 10 days of observation showed that complete resolution was achieved by Zinc Oxide in 63% of the patients, while 68 % was achieved by Zinc Oxide with Allantoin. Most patient of Zinc Oxide (58%) achieved resolution in 2 to 4 days, as well as those on Zinc Oxide with Allantoin (47%), with mean of 4.36 ± 1.70 days and 4.68 ± 1.70 days respectively.

 

 The above baseline characteristics had p values of >0.05, which are not statistically significant. No treatment failure for Zinc Oxide and Zinc Oxide with Allantoin were noted among our patients with diaper dermatitis. However, Relative Risk computation showed that there is a greater tendency towards complete response to Zinc Oxide with Allantoin compared to Zinc Oxide which has a greater tendency towards partial response towards (RR = 0.92 CI: 0.58 to 1.46). No allergic reaction was noted on both treatment groups.

 

CONCLUSION: Zinc Oxide with Allantoin is effective for the treatment of ICCD, and there is also tendency towards complete response. But there is no significant difference in using Zinc Oxide or Zinc Oxide + Allantoin in the treatment of irritant contact diaper dermatitis.

 

KEYWORDS: dermatitis

   
   

  

 

                                                                                                                                                                                                                 

 

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