Comparison of the Effects of Breast Milk and Hamamelis virginiana (Witch Hazel) on the Healing of Diaper Dermatitis in Infants: A Randomized Trial

Abstract

Background:

Diaper dermatitis (DD) is a very common problem in infants between 1 and 6 months. While it rarely causes long-lasting problems, it can cause serious short-term problems for both infants and parents. Accordingly, this study compared the effect of breast milk and diaper rash cream containing Hamamelis virginiana (12 mg/100 g) on the healing process in 0–6 month-old infants with DD.

Methods:

This randomized, single-blinded trial was conducted with 60 infants aged 0–6 months diagnosed with DD. Participants were assigned to either the breast milk group (BG) or the comparison group (CG) receiving Hamamelis virginiana cream. Demographic characteristics and DD severity were assessed using a structured demographic questionnaire and the validated Assessment of the Severity of Uncomplicated DD in Infants Scale. Statistical analyses included Shapiro–Wilk, Mann–Whitney U, Wilcoxon signed rank, Chi-square, and Fisher’s exact tests. Significance was set at p < 0.05.

Results:

Before the intervention, the mean scale score was 5.17 ± 0.46 in the BG, 2.83 ± 1.37 in the CG, which was a statistically significant difference. After the intervention, there was a significant decrease in the mean scale score in the BG to 0.03 ± 0.18, whereas the mean decrease was smaller in the CG (1.53 ± 1.11). The difference in the mean scale scores between the groups was statistically significant (p < 0.001). Furthermore, the postintervention mean scale score of the BG was significantly lower than that of the CG. However, baseline severity differences limit direct comparison of treatment efficacy.

Conclusions:

Topically applied breast milk appears to be a safe, accessible, and cost-effective option for treating uncomplicated DD, with greater improvement than cream containing Hamamelis virginiana. However, baseline severity differences limit direct comparison. Further studies using block randomization are recommended.

Keywords

infant diaper dermatitis breastmilk randomized controlled trial

Introduction

Diaper dermatitis (DD) is a common skin condition that usually presents as a rash on the diapered areas of infants. Although it rarely causes long-lasting problems, it can cause serious short-term distress for both infants and parents. During dermatitis, the infant’s skin is irritated by friction with the diaper, moisture, and exposure to changing pH. If precautions are not taken, bile salts and other irritants in feces break down the protective lipids and proteins in the upper layer of the skin, causing urine to mix with the feces, thereby increasing skin pH and disrupting its integrity.^1,2

Because families generally do not consider DD to be a disease, they tend to treat it at home, which means there are no clear data regarding its prevalence.³ Previous studies in various countries indicate a prevalence of 15.2–60.3%⁴ while global studies report prevalence rates between 23.9% and 61.5%.⁵ DD is generally treated using both pharmacological and nonpharmacological methods. Regarding the former, cream using extract of Hamamelis virginiana (HV) (potency 12 mg/100g) can reduce inflammation and irritation, making it a potential candidate for treating conditions such as eczema, burns, and other skin irritations. The extract is commonly used in topical preparations for its soothing effects on the skin.⁶

DD is a common inflammatory skin condition that affects approximately 7–35% of infants, with prevalence varying by age, hygiene practices, and geographic region.⁷ It typically results from prolonged exposure to moisture, friction, and irritants such as bile salts and fecal enzymes, which compromise the epidermal barrier and increase susceptibility to inflammation.⁸ The condition is most frequently observed between 9 and 12 months of age and is often underreported due to informal home management.⁹

HV (witch hazel) is a botanical extract containing tannins, flavonoids, and volatile oils, known for its anti-inflammatory, astringent, and mildly antiseptic properties. It is commonly used in topical formulations for managing skin irritation, including minor burns, eczema, and diaper rash. Although its composition may vary across commercial preparations, pharmacological studies support its role in reducing inflammation and promoting skin healing.¹⁰

Breast milk contains immunologically active components such as secretory immunoglobulin A, lysozyme, lactoferrin, and anti-inflammatory cytokines, which contribute to its antimicrobial and skin-repairing effects.¹¹ Several randomized controlled trials have investigated its topical use for DD. Gözen et al. (2014) found that barrier cream was more effective than breast milk in treating moderate-to-severe DD,¹² while Farahani et al. (2013) reported comparable efficacy between breast milk and 1% hydrocortisone over a 7-day treatment period.¹³ Seifi et al. (2017) demonstrated significant improvement in rash scores with breast milk application on days 1 and 3.⁹ These findings suggest that breast milk may be a safe and accessible alternative for uncomplicated DD, though further studies are needed to confirm its comparative effectiveness.

One of the nonpharmacological methods for treating DD is topically applied breast milk, which is an effective treatment method for DD^14–17 while having lifelong positive effects through breastfeeding.¹⁸ More specifically, breast milk’s antibacterial and antimicrobial properties enable it to inhibit the growth of the bacteria that cause DD and reduce the risk of infections, while its anti-inflammatory components soothe the skin and reduce inflammation.¹⁹ By raising the skin’s moisture content, topical breast milk administration can also reduce the dryness and irritation that DD causes by upsetting the skin’s moisture balance. Finally, breast milk also has properties that help the body fight infections.¹⁸

Studies into the efficacy of using breast milk for treating DD have produced varying results. Gözen et al. (2014) compared the effect of breast milk and barrier cream for treating moderate and severe dermatitis, finding that barrier cream was more effective than breast milk. Farahani, Ghobadzadeh, and Yousefi (2013) conducted a randomized controlled study to compare the effects on DD of administering 1% hydrocortisol or breast milk for 7 days.¹⁹ They found similar improvements on the 3rd and 7th days of treatment, concluding that breast milk is a safe and effective treatment option. Finally, Seifi et al. (2017) compared and tested the use of breast milk for DD treatment, finding a significant difference in favor of breast milk in reducing skin rash scores on the first and third days of application.

Materials and Methods

Aim

It is important for nurses to know the risk factors of DD, plan preventive care, and convey up-to-date information to parents. When an infant develops DD, nurses should provide appropriate, evidence-based care. Because breastfeeding is a free method that mothers can easily adapt to, all mothers should be encouraged to breastfeed in the postpartum period to ensure that their babies can benefit from breastmilk, which can be used topically in treating DD. Accordingly, the aim of this study was to compare efficacy of HV (potency 12 mg/100 g) with breast milk in treating infant DD.

Study design

This study adopted a randomized controlled and single-blinded design. The study was registered with ClinicalTrials.gov (Clinical Trials Number: NCT06699303). The 2022 guidelines for reporting outcomes in trial reports (CONSORT; Fig. 1) were followed.²⁰

FIG. 1.

Consort flow diagram.

Randomization: A closed envelope application was used for randomization. The envelopes were written as “care with breast milk” and “care with diaper rash cream,” and mothers who agreed to participate in the study were asked to draw one of these envelopes. After their informed consent was obtained, the mothers were included in the care group that came out of the envelope.

Setting and participants

The study population was 1–6-month-old infants with DD, whose mothers had been admitted to hospital’s Pediatrics Outpatient Clinic. Because not all infants with DD are treated at the hospital, the population size is not known precisely. The GPower 3.1.9.2 package program was used to calculate the sample size. No previous study was found that used Assessing the Severity of Uncomplicated DD in Infants Scale (ASUDDIS). Therefore, the sample size was calculated as 26 for each group with the assumption of a 95% confidence interval and 0.8 effect value for 80% power for the t test in which the means of two independent groups were compared by means of “A priori: Computer quired sample size.” Considering that there could be missing participants in the sample, 30 infants were included in each group. The post hoc power analysis was performed using the GPower 3.1.9.2 package program, while ASUDDIS was used for the power calculation, resulting in a power of 99.9%.

Inclusion criteria

Infants diagnosed with DD by a pediatrician between 1 and 6 months of age, exclusively breastfed, without diarrhea or thrush, without a history of skin diseases, such as fungus, eczema, or allergy, without antimycotic, antibiotic, or steroid use, without previous application of medication, barrier creams, or powder to the area affected by DD.

Exclusion criteria

Babies with health problems other than DD, using additional medications, not brought to the check-ups, or with mothers who chose to leave the study without declaring their reasons.

Data collection tools

Data were collected using a form with 13 questions about the infant’s sociodemographic characteristics and the ASUDDIS with 4 items.

The ASUDDIS was developed and validated by Buckley et al., with a reported Cronbach’s alpha of 0.702. In our study, the scale demonstrated acceptable internal consistency with a Cronbach’s alpha of 0.78.²¹

The ASUDDIS has four items. Users rate the items as follows to produce a total score ranging from 0 to 6: severity of erythema or irritation (0–3); degree of glandular dermatitis (0–1); papules and pustules (0–1); open skin (0–1). Thus, a low total score indicates low DD severity, whereas a high score indicates high severity.²¹

Implementation and data collection

The study was conducted with 1–6-month-old infants and their mothers who were admitted to the hospital’s Obstetrics and Gynecology outpatient clinic between May 1 and May 10, 2023. Babies from this age range were selected because mothers in Turkey generally breastfeed their babies exclusively during this period, so they should be able to supply breastmilk for topical DD treatment. Once the babies had been diagnosed with DD by a pediatrician, the mothers were referred to the midwives/nurses working in the outpatient clinic. After informing the mothers who met the inclusion criteria about the study, the midwives/nurses obtained their informed consent and asked them to draw one of the papers in sealed envelopes to assign their infant to one of the two groups (treatment with breast milk or HV (potency 12 mg/100g).

In the breast milk group (BG), breast milk was used for treating the babies’ DD, while HV cream (potency 12 mg/100 g) was used for the babies in the comparison group (CG). HV (potency 12 mg/100 g) was preferred because it is frequently used for treating uncomplicated DD in the hospital where this study was conducted.

Breast milk group

The midwives/nurses informed the mothers about the application of breast milk to the diaper rash area and the dates of the follow-up visits. Regarding the routine for changing the diaper, the mothers were instructed to remove the diaper and then wash and dry their hands with soap and water before applying breast milk directly by gently massaging with their fingertips into the area affected with dermatitis. After allowing the area to dry, they were asked to put on a fresh diaper. After each diaper change, mothers were asked to apply breast milk to the affected area of their newborns.

Comparison group

The mothers in the CG were instructed to wash and dry the diaper area with soap and water after removing the diaper before applying diaper rash cream containing HV (potency 12 mg/100g). After each diaper change, mothers were asked to apply HV(potency 12 mg/100g) to the affected area.

Mothers in both groups were asked to record positive and/or negative effects of the treatment, including new signs and symptoms that developed in the area affected by DD, and inform the investigators about them at the next follow-up visit.

The mothers in both groups were also given the following instructions:

To use neutral cleansers without chemicals like perfumes or colorants for cleaning the infant’s skin, to use a good quality ready-made diaper with good absorbency and breathability, to keep the diaper area dry, clean, to change the diaper immediately after each stool or at least five times a day, to wash and dry the perineum with warm water and soap after defecation, to avoid tightening the diapers too much, to avoid dressing the infant in tight clothes, to ventilate the infant’s room frequently, making sure it is not too hot or humid, to clean the genital area gently using soft movements during diaper changes, to clean the perineum from the clean area toward the dirty area (from top to bottom), to use alcohol-free cotton wipes soaked in water and then wrung out for cleaning.

Evaluation of improvement in DD symptoms was performed single blindedly by the physician working in the relevant outpatient clinic. Pretest data were collected on the day of diagnosis and post-test data were obtained by inviting the infants to the clinic for the post-test on the 5th day. Data on DD were collected by the one author.

It was planned that, on the 5th day of the intervention, the babies in both groups would be referred to a dermatologist in line with the ethical principle of “do no harm” for those cases that experienced no improvement. However, there were no such cases requiring referral to the dermatologist.

Blinding

The physician who diagnosed DD and performed the evaluations evaluated the improvement on the 5th day of the intervention in the outpatient clinic without knowing which group the babies were in (single blind) and recorded the results using the ASUDDIS.

Data analyses

SPSS 26 (Statistical Package for the Social Sciences) program was used for the statistical analysis. The quantitative variables were expressed as mean, standard deviation, median, and min and max values, while the qualitative variables were expressed as frequencies and percentages using descriptive statistical methods. The Shapiro–Wilk test and box plot graphs were used to confirm that the data conformed to a normal distribution.

The Mann–Whitney U test was used to compare the two groups, while the Wilcoxon signed rank tests were used to compare intragroup values. Chi-square and Fisher’s exact Chi-square tests were used to compare qualitative data. The results were evaluated at 95% confidence interval and significance was set at p < 0.05 level. A post hoc test was performed for the power analysis.

Ethical approval and informed consent

Institutional permission was obtained from the institution where the study was conducted. Ethics Committee approval dated February 12, 2023, numbered E-16214662-050.01.04-220310-04 was obtained from the Sakarya University Faculty of Medicine, Interventional Studies Ethics Committee. The study was conducted according to the Declaration of Helsinki. Mothers who brought infants aged 1–6 months for examination and whose infants had confirmed DD were informed about the study, and their written informed consent was obtained. The mothers were informed that they could leave the study at any time without giving any reason and that the study would not bring any financial burden.

Hypotheses

This study tested the following null and alternative hypotheses: H₀

There is no difference in the rate of healing between DD cases treated topically with breast milk or with cream containing HV (potency 12 mg/100 g).

H₁

The rate of healing DD cases treated with breast milk is higher than DD cases treated with cream containing HV (potency 12 mg/100 g).

Results

Regarding demographic characteristics, 46.7% of the babies were male (n = 28) while 53.3% were female (n = 32); the mean age was 3.37 ± 1.26 months; the mean weight of the babies was 5774.17 ± 1273.17 g (range: 3,500–9,500 g). All of the babies (n = 60) were admitted to the outpatient clinic because of redness in the genital area. Regarding educational status, 50.0% (n = 30) of the mothers had an undergraduate or higher education level.

There were statistically insignificant differences between the babies in the BG and CG groups in terms of the infants’ gender, age, and weight or the mothers’ educational status (p > 0.05, Table 1). That is, the participants were homogeneously distributed between two groups.

Table 1.

Comparison of Descriptive Characteristics of the BG and CG Babies and Mothers

	BG (n = 30)	CG (n = 30)	p
Gender
Male	14 (46.7)	14 (46.7)	^a1.000
Female	16 (53.3)	16 (53.3)
Age
Mean ± SD	3.37 ± 1.21	3.37 ± 1.32	^b1.000
Median (Min–Max)	3 (1–6)	3 (1–6)
Weight (g)
Mean ± SD	5668.3 ± 1055.32	5880.71 ± 1470.02	^b0.525
Median (Min–Max)	5,350 (3,800–8,100)	6,000 (3,500–9,500)
Mother’s education
Primary education	3 (10.0)	5 (16.7)	^c0.824
High school	11 (36.7)	11 (36.7)
Undergraduate, above	16 (53.3)	14 (46.6)

Pearson Chi-square test.

Student-t test.

Fisher Freeman Halton Test.

BG, breast milk group; CG, control group; SD, standard deviation.

Regarding preintervention diaper changing care practices, 40% of the mothers in BG and 73.4% of the mothers in CG reported changing diapers every 2–4 hours; 63.3% of the mothers in BG and 53.3% in CG reported cleaning the diaper area with wet wipes; 96.7% of mothers in BG and 66.7% in CG reported allowing diaper area to air dry; 60% of mothers in BG, 43.3% in CG mothers reported bathing the infant every other day. The two groups differed significantly in terms of daily diaper changing (p = 0.038) and ventilation of the perineum (p = 0.006) (Table 2).

Table 2.

Comparison of the Infants Characteristics Related to Preintervention Diaper Area Care

	BG (n = 30)	CG (n = 30)	p
Diaper change frequency
2–4 hours	12 (40.0)	22 (73.4)	^q0.038**
5–6 hours	8 (26.6)	6 (20.0)
7–8 hours	5 (16.7)	1 (3.3)
After infant defecates	5 (16.7)	1 (3.3)
Cleaning method
With soap and water	3 (10.0)	5 (16.7)	^q0.523
With a wet wipe	19 (63.3)	16 (53.3)
Water only	8 (26.7)	9 (30.0)
Ventilation status
Ventilated	29 (96.7)	20 (66.7)	a0.006*
Not ventilated	1 (3.3)	10 (33.3)
Bath frequency
Once a day	3 (10.0)	8 (26.7)	^q0.224
Every other day	18 (60.0)	13 (43.3)
Every 3 days or fewer	9 (30.0)	9 (30.0)

Fisher Exact test.

Fisher Freeman Halton Test.

*p < 0.01.

**p < 0.05.

BG, breast milk group; CG, control group.

For the infants in BG, the pretest ASUDDIS scores were 5.17 ± 0.46 (Min:4, Max:6), while the CG scores were 2.83 ± 1.37(Min:1, Max:6), which was a statistically significant difference (p = 0.001). The BG and CG post-test ASUDDIS scores were 0.03 ± 0.18 (Min:0, Max:1) and 1.53 ± 1.11 (Min:0, Max:4), respectively, which was also a statistically significant difference (p = 0.001, Table 3).

Table 3.

Distribution of Infants’ Pre- and Postintervention ASUDDIS Scores

ASUDDIS scores		BG (n = 30)	CG (n = 30)	p
Before Implementation	Mean ± SD	5.17 ± 0.46	2.83 ± 1.37	^a <0.001*
Before Implementation	Median (Min–Max)	5 (4–6)	2.5 (1–6)
After Implementation	Mean ± SD	0.03 ± 0.18	1.53 ± 1.11	^a <0.001*
After Implementation	Median (Min–Max)	0 (0–1)	1 (0–4)

	p	^b <0.001**	^b <0.001**
Change	Mean ± SD	−5.13 ± −0.51	−1.30 ± 1.15	^a <0.001*
Change	Median (Min–Max)	−5 (−6 to −4)	−1 (−5 to 0)

Mann–Whitney U test.

Wilcoxon Signed Rank test.

*p < 0.001.

SD, standard deviation.

In BG, the post-test ASUDDIS scores decreased by 5.13 ± 0.51 compared with the pretest scores, which was a statistically significant decrease (p = 0.001). The minimum and maximum scores were 6 and 4 units lower, respectively, than in the pretest. In CG, the scores decreased by 1.30 ± 1.15 compared with the pretest scores, which was also a statistically significant decrease (p = 0.001). The minimum and maximum scores were 5 and 0 units lower, respectively, than in the pretest (Table 3).

While ASUDDIS scores were significantly lower in both groups following the intervention, the post-test decrease compared with the pretest scores was statistically significantly higher in BG (p = 0.001) than in CG (p < 0.01), (Table 3, p < 0.01; Fig. 2).

FIG. 2.

Post-test changes in ASUDDIS scores for BG and CG. This line graph illustrates the comparison of the mean scores on the ASUDDIS for infants in the BG and the CG before and after the 5-day intervention. Key findings (Graph Values): BG: The pre-test mean score was 5.17, and the post-test mean score decreased significantly to 0.03. CG: The pretest mean score was 2.83, and the post-test mean score decreased to 1.53. While a significant improvement was observed in both groups, the decrease in the BG was statistically significantly higher compared to the CG ($p = 0.001$). ASUDDIS, Assessment of the Severity of Uncomplicated Diaper Dermatitis in Infants Scale; BG, Breast milk group; CG, Control group (Hamamelis virginiana cream).

Discussion

DD, which is one of the most common skin problems in infancy, can be treated using various medicines or traditional methods.^16,22 Regarding non-pharmacological treatment methods, olive oil and breast milk are commonly used.^8,16,23,24

In the present study, there were some behavioral differences between the mothers in the two groups.²⁵ First, the babies in CG had their diapers changed significantly more frequently than the babies in BG (p = 0.038, Table 2). Previous studies have found that changing diapers two or more times a day reduces the risk of DD.²⁰ Mothers in the BG group apparently changed their infant’s diapers less frequently than those in the CG group before the intervention, which may explain the higher mean pre-test ASUDDIS score for BG (Table 3). Conversely, mothers in BG ventilated the diaper area significantly more than the mothers in CG (p = 0.006, Table 2). Previous studies have shown that ventilation of the diaper area has been shown to reduce DD severity.²⁶ In our study, mothers in both groups were given identical instructions about caring for their infants’ perineum and to use diapers with similar characteristics in order to rule out any effects that may arise from differences in caring practices. In addition, infants with diarrhea or comorbidities were excluded from the sample.

We found a statistically significant difference between the pre- and postintervention infants’ mean ASUDDIS scores (p = 0.001, Table 3). More specifically, topical treatment with milk improved DD faster than HV (potency 12 mg/100 g) (Fig. 2). Due to its antibacterial and antimicrobial properties, breast milk can inhibit the growth of bacteria that cause DD, thereby reducing the risk of infection.^16–19,23 Thus, if mothers are breastfeeding then breast milk provides a readily available and free option for treating DD.

The preintervention ASUDDIS scores were significantly higher in BG than in CG (Table 3), whereas the postintervention scores were significantly lower in BG than in CG (Table 3). That is, the intervention had a significantly larger effect on the ASUDDIS scores in the BG group compared with the CG group.

While no previous study has directly compared topical breast milk treatment and HV treatment (potency 12 mg/100 g), our findings confirm those of previous studies showing that topically applied breast milk is an effective treatment option for DD.^{17–19,21–24} Thus, topically applied breast milk can be considered an effective method for treating DD that is both cost effective and has no drug-related side effects. Hence, breast milk should be recommended for DD treatment because, as long as mothers are breastfeeding, it is available at any time and has rapid healing properties. That is, we can accept H₁ hypothesis.

Limitations of the study

Although it is positive that the single-blind evaluation was conducted, the fact that the data were not collected by someone independent of the study is one of our limitations. Additionally, the absence of a placebo or untreated control group limits the ability to isolate the specific effects of each intervention. In addition, the fact that no additional evaluation was made other than the evaluation of treatment effectiveness on day 5 is another limitation. Having only one follow-up point (day 5) restricts the ability to assess long-term outcomes or delayed effects. Another limitation of our study is the lack of block randomization according to the severity of DD. This resulted in a baseline severity imbalance between groups, which may have influenced the comparative treatment outcomes. Since these data were collected in a single hospital, the findings may not be generalizable to other regions, health care settings, or populations with different hygiene norms. The single-center design further limits the external validity of the study.

Conclusion

This single-blinded randomized controlled trial demonstrated that breast milk can be used for uncomplicated DD and heals faster than hydrocortisone (12 mg/100 g). Breast milk may offer a safe, accessible, and cost-effective treatment for uncomplicated DD. Due to methodological limitations, findings should be interpreted cautiously. Consequently, we can conclude that using breast milk for DD is cost-effective, and mothers can easily assess its availability.

Declaration on Data Sharing

Data will be shared if requested.

Consent from Participants

Obtained as stated in article.

Authors’ Contributions

D.S.G.: Conceptualization, methodology, formal analysis, writing—original draft, visualization, and project administration. G.V.: Conceptualization, methodology, formal analysis, writing—original draft, visualization, and project administration. Z.T.: Conceptualization, methodology, resources, writing—original draft, and project administration, F.Ü.T.: Conceptualization, methodology, resources, and writing—original draft. H.E.M.A.: Conceptualization and interpretation of data for the study. All authors approved the final version of the article for publication.

Footnotes

Acknowledgments

The authors would like to thank all the mothers for their contributions.

Funding Information

This studies did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data Availability

Data available from the corresponding author upon reasonable request.

Disclosure Statement

The author(s) declared no potential conflicts of interest with respect to the studies, authorship, and/or publication of this article.

Supplemental Material

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