Evaluation of safety and efficacy of prickly heat baby powder in 0-36 months babies

INTRODUCTION

A baby’s skin is delicate and sensitive in nature, significantly differing from adult skin in both structure and function. Understanding these differences is crucial for effective care during the early stages of life. A child's skin undergoes significant maturation and development, adapting from the delicate nature of infant skin to a more resilient form. Skin maturation begins at birth and continues throughout the first few years of life. By the end of the first year, infant skin starts to resemble adult skin more closely, with structural and functional improvements occurring continuously.^1,2 The stratum corneum (SC) thickens and the epidermis becomes more organized, leading to better barrier function and reduced trans epidermal water loss (TEWL) over time. Due to smaller corneocytes, wider spaces between corneocytes, a thinner stratum corneum, fewer normal microflora and lower skin lipid, newborn skin is more susceptible to dryness than adult skin.^3-5 Excessively dry skin can cause infection and damage to the skin barrier. Prickly heat, also known as heat rash or miliaria, is a common dermatological condition characterized by small, itchy red bumps and arises when sweat glands become blocked, leading to inflammation and discomfort. This condition is particularly prevalent during hot and humid weather, where babies are more susceptible to excessive sweating.⁶ The primary symptom of prickly heat is intense itching, which can cause significant discomfort for infants and toddlers. This constant itching often leads to irritability and fussiness, making it difficult for caregivers to soothe them. The discomfort from the rash also interferes with their sleep patterns.

Babies may wake frequently due to the itching sensation, leading to fatigue for both the child and the parents. The persistent discomfort can result in behavioural changes, such as increased restlessness or difficulty engaging in play, which are crucial for a child's development. Its symptoms can significantly diminish the quality of life for newborns and toddlers through physical discomfort, emotional distress and social implications. Effective management strategies are essential to mitigate these effects.

The delicate skin of infants requires special care to prevent and alleviate the symptoms associated with prickly heat, making effective skincare products essential for maintaining their comfort. The chances of contracting these symptoms in infants and children is comparatively higher due to their less mature barrier function and sweat ducts which may also lead to heat rashes.⁷ Consequently, topical products for infants should be carefully formulated such that preparations should minimize the use of irritating/sensitizing ingredients.

Using safe and well-tolerated natural infant care products is essential to protecting the skin barrier of newborns and toddlers, who are frequently exposed to a variety of external factors. This explains the growing demand for natural ingredient-based products among consumers and medical experts. The “Prickly heat Baby Powder” is a polyherbal formulation recommended for reduction and prevention of rashes and itching to the baby’s skin and it contains the oils of Santalum album, Vetiveria zizanoides and Olea europaea and the powder of Yashada bhasma.

To confirm non-allergenic potential of prickly heat powder, it was evaluated through HRIPT on 200 adults (male/female) healthy volunteers as a standard development process of topical products (BIS4011:2018 guidelines).⁸ The results of a study evaluating the safety and efficacy of prickly heat baby powder for newborns, babies and toddlers are presented in this article.

METHODS

Study design

This was an open label, single arm, multicentric study conducted to assess the tolerability, safety and effectiveness of Prickly heat baby powder after use for 15 days period. This study included 500 subjects (N) and parents were instructed to sprinkle the test product on to their palms and apply on baby’s skin after bath, nappy changes and before bed-time.

24 distinct medical facilities (out-patient clinics/ hospitals) around India were included in this multicentric study, ensuring a wide geographic distribution and eliminating the contingency of bias (1. Poddar Hospital, Jaipur 2. Shivnath Children Hospital, Vadodara 3. GSVM Medical College, Kanpur; 4. Chinmay Institute of Pediatrics, Pune 5. Mediclin Polyclinic and Pharmacy, Bhubaneswar 6. Dr. Bhargava Clinic, Ghaziabad 7. Sparsh Child Care and Gastro Centre, Lucknow 8. Jai Clinic, Ajmer 9. Shourya Childcare and Maternity Clinic, Bhopal 10. Citizen Hospital, Bangalore 11. Mangal Murti Children's Clinic, Pune 12. Dr. Agarwal's Clinic, Noida 13. B D Pathak Hospital, Rudrapur. 14. Brij Medical Centre, Kanpur; 15. Atmaram Child Care Hospital, Kanpur 16. Dr. V D Patil Patil Clinic, Belagavi 17. Navjot Eye and Children Clinic, Belagavi 18. Khalatkar Hospital, Nagpur 19. Shivam Children Hospital and Neonatal Care Centre, Ahmedabad 20. Pal Clinic, Howrah; 21. Dimension Medicare Centre, Kolkata; 22. Alliance Healthcare, Guwahati 23. Navkaar Clinic, Mumbai 24. FS Endocrine and Diabetic Centre, Telangana). The study lasted for a period of 15(+1-day Window period) days, beginning from Apr-2022 to Jul-2022.

Study subjects

Full-term newborns, infants and toddlers of age 0–36 months of either sex with one or more symptoms of prickly heat such as itching, redness and rashes due to friction (in elbows, arms and knees etc) were considered eligible for this study. Subjects were required to be in overall good health, as confirmed through pediatricians by recent medical history and physical examination. Subjects with a documented history of allergies requiring medical intervention, with a history of allergy to any of the components of the test products or those currently experiencing allergic conditions, as well as individuals with chronic illnesses were excluded from the study. Additionally, subjects whose parents or guardians were unwilling to halt the application of concomitant similar products throughout the study, were also excluded. A written informed consent was obtained from the subjects’ parent /LAR (Legally Authorized Representative).

Intervention/study product

The parents were instructed to sprinkle ‘Prickly Heat Baby powder” on to their palms and apply on baby’s skin (all over the body) after bath and whenever necessary for a period of 2 weeks. Parents were given a caution to avoid using it around baby’s eyes, nose, mouth and sensitive areas and not to sprinkle directly onto baby’s skin to avoid accidental inhalation. They were asked to discontinue the product, if they noticed any adverse effect. This study encompassed of two distinct visits: The initial visit, denoted as the screening, enrolment and test product application (Visit 1). The final assessment, known as end of study (EOS) Visit (Visit 2), took place on day 15±1.

Ethical conduct of the study

Before commencing the descriptive study, it underwent review and approval by Ethics committee (The Raneshwar Multispecialty Hospital Ethics Committee; Reg. No. ECR/1232/Inst/GJ/2019, approved on 20/08/2022) and in accordance with all applicable regulations ensuring that the rights, safety and welfare of trial subjects are prioritized, ICH–GCP (International council for harmonization of technical requirements for pharmaceuticals for human use-good clinical practice) requirements, Indian drug cosmetic act 1940, ICMR Guidelines and Declaration of Helsinki.⁹ This study was prospectively registered in Clinical Trials Registry of India (CTRI/2021/10/037163).

Safety and Efficacy Assessments

Safety was evaluated by paediatricians through the assessment of local intolerance, including symptoms like dryness, erythema, edema, scaling, itching, rashes and burning sensation. Any undesirable event was monitored and documented in accordance with COLIPA guidelines for adverse events (AE) and serious adverse events (SAE).¹⁰

Efficacy assessments included the dermatological evaluation of mildness and gentleness of the product on baby’s skin. This was assessed by pediatricians in every study visit. A Subjective assessment was recorded on Visit 1 (Baseline/ Day 1) and Visit 2 (EOS/Day 15+1) to appraise the overall suitability of the test product with respect to keeping the baby’s skin soft and smooth. The scoring provided by the subject’s parent/ LAR and was in turn correlated with response to the treatment. Additionally, symptom assessment questionnaire was filled by Subject’s parent / LAR at Visit 1 (Baseline/ Day 1) and Visit 2 (EOS/ Day 15) to assess the product’s efficacy in resolving the existing symptoms (rashes, itchiness etc). Moreover, at the end of the study, a subjective feedback questionnaire was used to capture the parents’ experiences with test product and gathering insights about the product from the perspective of users.

Statistical analysis

The subjects’ demographic details were analysed using descriptive statistics. Central tendencies, measures of dispersion, frequencies and percentages were used to summarize quantitative variables. To assess the significance of continuous variables, Wilcoxon matched pairs signed rank test was utilized, level of significance was fixed at a level of 0.05. Statistical analyses were conducted by GraphPad Prism version 6.07.

RESULTS

Demographic distribution of subjects

The demographic details, including age and gender, for each subject are shown in Table 1. Children of three different age groups were included in the study: 0 days to≤1 month, 1 month to≤12 months, 12 months to 36 months. In this study, 52.4% of the subjects were female and 47.6% were male maintaining equitable gender ratio.

Dermatological assessment

Dermatological Assessment in terms of frequency and percentage indicated that the test product was mild and gentle for infants' skin in over 90% of subjects, the test product was rated as good, very good and excellent in terms of parameters like mildness and gentleness. The responses were recorded by the Pediatricians at the End of Study. The details are given in Figure 1, Figure 2 and Table 2.

Subjective assessment questionnaire

The subjects’ parents/LAR completed subjective assessment questionnaires at the baseline and at the End of Study (EOS) (Details given in Table 3). The outcome was assessed based on 0-to-10-point scale for each question, Q1: 0=Not Soft 10=Very Soft, Q2: 0=Very rough 10=Very smooth. By EOS, 46.6 % of the subjects showed improvement in softness and 40.7% of the subjects showed improvement in smoothness of the skin demonstrating notable clinical validation of the prickly heat baby powder.

Symptom assessment questionnaire

Symptom assessment questionnaire was used to assess the effect of the test product in resolving the existing symptoms (rashes, itchiness etc) after use for 15 days. When compared to baseline, there was a significant reduction in rash and itchiness at EOS (Table 4) The Prickly heat powder resolved the prevailing symptoms in 68.6% of subjects (Table 5). Results indicated that the subjects had their symptoms resolved in 10 median days. The minimum number of days necessary for symptom resolution was 3, while the maximum number of days required was 16 (Table 6).

Subjective feedback for the product

At the end of the study, a subjective feedback questionnaire was used to capture the parents’ experiences with test product and gathering insights about the product from the perspective of users. After using the Prickly Heat Baby Powder for 15 days, 91% to 98% of the subjects’ parents /LAR expressed their acceptance by agreeing that the Prickly heat baby powder helps to relieve skin rashes, soothe and calm the irritated and red skin, relieve itching of baby's skin from prickly heat (Details given in Table 7). The subject’s parents/ LAR also appraised that the test product keeps baby’s skin cool, soft, moist-free and helps reduce the effects of rubbing and friction of baby’s skin. The fragrance of the Prickly heat baby powder was mild and its usage improved the overall condition of baby’s skin. Almost all subject’s parents/ LAR accepted that they felt good after using Himalaya prickly heat baby powder.

Adverse events and local intolerance

None of the subject had any adverse effects during the entire course of the study. All the subjects displayed an adequate acceptance to Prickly Heat Baby Powder. No worsening of dry skin was observed in any of the subject during the course of the trial. None of the parents/LAR of the subjects complained of any side effects or untoward reactions.

*Statistical test: paired t test/ Wilcoxon matched pairs signed rank test, level of significance was fixed at 0.05, CFB: Change from Baseline. Sd: Standard deviation.

*Assessed on 0-to-10-point scale, Q1: 0=Very itchy skin 10=No itching, Q2: 0=Severe red patches 10=No red patches, Q3: 0=Severe rashes 10=No rashes, Q4: 0=Many boils / blister 10=No rashes boils / blister, Q5: 0=Severe burning 10=No burning, Statistical test: Paired t test/ Wilcoxon matched-pairs signed rank test, level of significance was fixed at 0.05, CFB: Change from Baseline. Sd: Standard deviation.

EOS= End of Study

Min = Minimum, Max = Maximum, N: number of Subjects

DISCUSSION

This observational study has certain credentials like, this is a multicentric study, spanning over 24 pediatric centres across India with inclusion of 500 children of 0-36 months age group, adhered to high standards of clinical research, including registration with CTRI, approval by CDSCO registered Ethics Committee and adherence to ICH-GCP guidelines. Gender balance was maintained, enrolling roughly equal proportions of male and female infants, mitigating potential gender-based variations in outcomes.

The safety and effectiveness of the test product was evaluated in children from 0 to 36 months with at least one or more symptoms of prickly heat such as itching, redness and rashes due to friction (in elbows, arms and knees etc). The results of our study indicate that the test product was effective in resolving the symptoms and improving soothing and smoothing effect and feel of coolness on children’s skin.

The product has astringent properties that treat the rash and provides quick relief by alleviating inflammation and easing itchy sensation. The product also helped reduce child’s restlessness by providing an instant soothing action, while protecting the skin from further outbreaks and infections.

For many decades herbal medicinal products have been used for children’s health care.¹¹ Many natural molecules of plant origin, such as alkaloids, flavonoids, isoflavones, proanthocyanidins, phenolic compounds and essential oils, are associated with the treatment of many dermatological conditions.¹²

Himalaya Prickly Heat Baby Powder is formulated with natural ingredients like Yashada bhasma, Neem (Azadirachta indica), Karanja (Pongamia pinnata) and Khus Khus (Vetiveria zizanioides). Yashada Bhasma, a Zn based herbo-metallic preparation, is reported to possess significant antiseptic and anti-inflammatory properties and hence used in the management of various skin conditions including wound healing as it effectively soothes irritated skin rashes.¹³ The antibacterial, anti-inflammatory, antifungal and antiviral properties of neem’s active ingredients such as nimbidin, nimbin and nimbidol promote wound healing. In addition, neem contains high concentrations of minerals, vitamins and amino acids that are essential for wound healing during the proliferative phase.¹⁴

Neem oil is beneficial in managing itching, rashes and inflammation and its antioxidant property provides protection to baby’s skin.^15,16 Karanja is reported to possess significant antibacterial activity against skin pathogens. The emollient property of oil moisturizes and soothes the baby’s skin. The anti-microbial and anti-inflammatory properties helps relieve itching and wound healing property effectively heals rashes.¹⁷

The oil of the herb Vetiveri zizanioides is reported to possess astringent, antimicrobial and antiseptic activity. It is useful in skin care, as a tonic and detoxifier.¹⁸ It also plays a pivotal role in providing symptomatic relief and preventing further outbreaks.

In addition, Prickly heat baby powder is free from parabens, phthalates, talc and synthetic colors that may pose the greatest risk linked to skin damage and even cancer and therefore considered a safer recommendation for infants and children.¹⁹

This contrasts with some other brands that have faced criticism for causing rashes or discomfort upon application due to harsh chemicals or fragrances. Although study findings seem encouraging, it also had certain limitations.

Firstly, the study was open label which increases the chance of discriminatory disclosure leading to bias. The difficulty in designing a blinded study is recognized as a design limitation. Since the study had no objective parameter and comprised of only subjective assessments, lead to the possibility of reporting bias. In further investigations, objective assessments including clinical parameters, instruments and comparative photographs could be considered, resulting in more accurate, impartial and quantitative outcomes. As parents increasingly seek safe and effective solutions for their children's skincare needs, products like prickly heat baby powder will likely continue to gain traction.

The emphasis on natural ingredients not only aligns with contemporary consumer preferences but also addresses health concerns associated with synthetic alternatives. Formulated with herbal ingredients, the test product is proven safe and effective with no adverse events.

CONCLUSION

Through this clinical study prickly heat baby powder has been verified for its safety, tolerability and effectiveness for newborns and infants. Mothers/Caretakers noted the effectiveness of the product in resolving the prickly heat symptoms and study also validates the products' mild and gentle nature, ensuring to provide full care to the baby’s delicate skin. For parents looking for a reliable solution to manage prickly heat during hot weather, Prickly Heat Baby Powder offers a reliable option that combines tradition with advance knowledge in the area to prove its safety and efficacy.

ACKNOWLEDGEMENTS

We express our sincere appreciation to all the subjects and their parents/LAR for their participation in this study. We thank all the study investigators, study co-ordinators, and the study team for their role in conducting this clinical research. We extend our thanks to Dr. Archana R Shetty, Ms. Anusha (Medical Writer) for their contribution in manuscript preparation.

Funding: This study was funded by Himalaya Wellness Company, Bengaluru, India

Conflict of interest: Dr Rajesh Kumawat is an employee of Himalaya Wellness Company.

Ethical approval: The study was approved by the Institutional Ethics Committee (The Raneshwar Multispecialty Hospital Ethics Committee)

REFERENCES

1. 1. Rahma A, Lane ME. Skin Barrier Function in Infants: Update and Outlook. Pharmaceutics. 2022;14(2):433.
2. 2. Siri DK, Vikas J. Infant’s Skin and Care Needs With Special Consideration To Formulation Additives. Asian J Pharm Clin Res. 2018;11(12):75-81.
3. 3. Atrux-Tallau N, Huynh NT, Gardette L, Pailler-Mattéi C, Zahouani H, Viviant E, et al. Effects of physical and chemical treatments upon biophysical properties and micro-relief of human skin. Arch Dermatol Res. 2008;300(5):243–51.
4. 4. Alanen E, Nuutinen J, Nicklén K, Lahtinen T, Mönkkönen J. Measurement of hydration in the stratum corneum with the Moisture Meter and comparison with the Corneo-meter. Skin Res Technol. 2004;10(1):32–7.
5. 5. De Paepe K, Houben E, Adam R, Wiesemann F, Rogiers V. Validation of the Vapo Meter, a closed unventilated chamber system to assess transepidermal water loss vs. the open chamber Tewameter®. Skin Res Technol. 2005;11(1):61–9.
6. 6. Wenzel FG, Horn TD. Nonneoplastic disorders of the eccrine glands. J Am Acad Dermatol. 1998;38(1):1–20.
7. 7. Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Investig Dermatol. 2008;128:1728–36.
8. 8. Bureau of Indian Standards, 2016, Methods of test for safety evaluation of cosmetics (Third Revision). Available at: https://www.services.bis.gov.in. Accessed on 01^st January 2024.
9. 9. ICH harmonised guideline. Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice ICH E6(R2) Current Step 4 version dated 9 November 2016. Available at: https://database.ich.org/sites. Accessed on 21 August 2024.
10. 10. Cosmetics Europe: Guidelines on the Management of Undesirable Event Report; August,2005, - The Personal Care Association Avenue Herrmann-Debroux 40, 1160 Brussels. Available at: www.cosmeticseurope.eu. Accessed on 01^st January 2025.
11. 11. Marquardt P, Kaft K, Nieber K. Clinical trials with herbal medicinal products in children: a literature analysis. Wien Med Wochenschr. 2015;165(11-12):236-42.
12. 12. Afaq F, Katiyar SK. Polyphenols: skin photoprotection and inhibition of photocarcinogenesis. Mini Rev Med Chem. 2011;11(14):1200-15.
13. 13. Datta HS, Mitra SK, Patwardhan B. Wound healing activity of topical application forms based on ayurveda. Evid Based Complement Alternat Med. 2011;1:134378.
14. 14. Subapriya R., Nagini S. Medicinal properties of neem leaves: a review. Curr Med Chem Anticancer Agents. 2005;5(2):149–56.
15. 15. Mensah EE, Firempong CK. Chemical characteristics of toilet soap prepared from neem (Azadirachta indica A. Juss) seed oil. Asian J Plant Sci Res. 2011;1(4):1-7.
16. 16. Mohammad Asif. Antimicrobial Potential of Azadirachta Indica against Pathogenic Bacteria and Fungi. J Pharmacog Phytochem. 2012;1(4)78-83.
17. 17. Baswa M, Rath CC, Dash SK, Mishra RK. Antibacterial activity of Karanj (Pongamia pinnata) and Neem (Azadirachta indica) seed oil: a preliminary report. Microbios. 2001;105(412):183-9.
18. 18. Champagnat P, Sidibé L, Forestier C, Carnat A, Chalchat JC, Lamaison JL. Antimicrobial Activity of Essential Oils from Vetiveria nigritana and Vetiveria zizanioides Roots. J Ess Oil Bearing Plants. 2007;10(6):519–24.
19. 19. Andrea C. Gore. Executive Summary to EDC-2: The endocrine society's second scientific statement on endocrine-disrupting chemicals. Endocrine Rev. 2015;3:593-602.