Research Article - Journal of Dermatology Research and Skin Care (2023) Volume 7, Issue 6

Evaluating the Dermal Safety and Skin Compatibility of Personal Care Cosmetic Products Formulated with Natural Ingredients: An In-Vivo Primary Irritation Patch Test Study.

¹Medical Advisor, Department of Medical Advisors, Vedistry Private Limited. 21, Evergreen Industrial estate, Shakti mills lane, Mahalaxmi, Mumbai, India

²Medical Director, Department of Clinical Trials, NovoBliss Research Private Limited, Shaligram Lakeview, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar, India

³Consultant Dermatologist, Department of Consumer Research, Cliantha Research, Garden View, Auda Garden, Bodakdev, Ahmedabad, India

⁴Dermatologist, Department of Clinical Research, MASCOT-SPINCONTROL INDIA PVT. LTD., Kohinoor Estate, Lower Parel-West, Mumbai – 400013, India.

⁵Director Operations, Department of Clinical Trials, NovoBliss Research Private Limited, Shaligram Lakeview, Nr. Vaishnodevi Circle, Khoraj, Gandhinaga, India

*Corresponding Author:

Maheshvari Patel
Director Operations, Department of Clinical Trials
NovoBliss Research Private Limited
Shaligram Lakeview, Nr. Vaishnodevi Circle
Khoraj, Gandhinaga, India
E-mail: maheshvari@novobliss.in, maheshvaripatel3@gmail.com

Received: 27-Nov-2023, Manuscript No. AADRSC-23-121435; Editor assigned: 29-Nov-2023, PreQC No. AADRSC-23-121435(PQ); Reviewed: 13-Dec-2023, QC No AADRSC-23-121435; Revised: 18-Dec-2023, Manuscript No. AADRSC-23-121435(R); Published: 25-Dec-2023, DOI:10.35841/aadrsc-7.6.176

Citation: Mishra M, Patel N, Pandya I,et al. Evaluating the dermal safety and skin compatibility of personal care cosmetic products formulated with natural ingredients: An in-vivo primary irritation patch test study. Dermatol Res Skin Care. 2023;7(6):176

Abstract

Background: Cosmetic products have been widely used by the public for an extended period, emphasizing the high importance of ensuring their safety. Although cosmetic ingredients undergo skin irritation testing before entering the market, there is no obligatory mandate for producers to conduct final formulation testing.
Objective: The aim of this investigation was to assess the potential dermal irritation in individuals with diverse skin types when exposed to cosmetics and personal care formulations with natural ingredients. This evaluation utilized a single 24-hour application patch test method on healthy human subjects.
Methods: The dermal irritation potential of 26 personal care products of Vedistry Private Limited was tested following ethical principles and guidelines for Good Clinical Practice, IS 4011:2018 Methods of Test for Safety Evaluation of Cosmetics, CHD 25: Soaps and Other Surface-Active Agents Sectional Committee (first revision) and IS 13424:2001 Safety evaluation of bathing bars and toilet soaps. The products were applied on the subject’s back region i.e., between the scapula and waist. Application sites were evaluated for scoring the reaction, namely, erythema, dryness, wrinkles on a 0–4-point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours. The mean irritation score was computed through an excel-based calculation method.
Results: At both 30 minutes and 24 hours after removing the patches containing test products and controls, all 26 test products with a mean irritation score below 2.0 were determined to be non-irritating and safe for skin use. The negative control, showing a mean irritation score below 2.0, was confirmed as non-irritant. Conversely, the positive controls, which exhibited a mean irritation score surpassing 2.0, were identified as mild irritants at both the 30-minute and 24-hour assessments following patch removal. No subjects experienced serious adverse events or test product-related adverse event.
Conclusion: Vedistry's moha: Personal care product line, crafted with natural ingredients for both skin and hair care, adheres to dermatological safety standards. Following a 24-hour primary irritation patch test conducted under occlusion, these products are classified as non-irritating, skin-compatible, and safe for diverse skin types-ranging from oily and mixed to dry, normal, and sensitive.

Keywords

Natural Ingredients, Cosmetics, Patch Testing, Irritation, Personal Care, Dermal Safety, Dryness.

Introduction

The increasing use of cosmetics and personal care products is driven by the desire for improved skin texture and enhanced attractiveness, addressing emotional and self-esteem concerns. With the growing popularity of these products, there's a rise in the incidence of unwanted effects, primarily mild to moderate skin irritation reactions. Hence, cosmetic product used in the market since the long period of time by the public, and the safety of the cosmetic products are more important. While cosmetic ingredients undergo skin irritation testing before marketing, there's no mandatory requirement for final formulation testing by producers [1,2]. Personal care products formulated with natural ingredients have gained popularity in recent years due to their perceived benefits. Additionally, these products are believed to be safer and better for the environment than synthetic alternatives [3]. Clinical studies evaluating the efficacy of personal care products formulated with natural ingredients have been conducted. For instance, a study evaluated the use of natural antioxidant extracts in personal care products such as hand cream, body oil, shampoo, clay mask, body exfoliating cream, and skin cleanser. The study found that these products were well-received by participants and showed promise in terms of their antioxidant properties [4]. Herbal personal care products contain natural antioxidants like vitamin-C [5]. Thus, natural products are believed to be gentler on the skin and less likely to cause irritation or allergic reactions.

Different types of patch test are used to evaluate the safety of the cosmetic products like single patch test, in-use patch test, human repeated insult patch test (HRIPT). Patch test is mainly used to identify the etiological factors of allergic contact dermatitis. This is one of the most scientific method used for the investigation of contact dermatitis [6]. Patch testing is standard approach to evaluate the irritation and sensitization. In-Vitro testing, animal experiments and human experiments are used to evaluate the safety of the cosmetics. The human patch test is useful method to test the primary irritation in the human body caused by direct contact with the skin [7].

Several patch testing studies were undertaken to evaluate the safety of different ranges of personal care products formulated based on natural ingredients for skin and hair including moha: Herbal Face Wash, moha: Herbal Scrub, moha: Aloe Vera Gel, moha: Rose Mist, moha: Herbal Lip Balm, moha: Herbal Sunscreen Lotion With SPF 50, Moha: Moisturizing Lotion, moha: Soap, moha: Rose And Almond Soap, moha: Scrub Soap, moha: Herbal Shower Gel, moha: Rejuvenating Massage Oil, moha: Foot Care Cream, moha: Nail Care Cream, moha: 5 In 1 Hair Oil, moha: Anti- Dandruff Hair Oil, moha: Herbal Shampoo, moha: Herbal Anti-Dandruff Shampoo, moha: Sulfate Free Herbal Shampoo, moha: Herbal Hair Conditioner, moha: Herbal Hair Serum, moha: Herbal Radiance Face Mask, moha: Overnight Lotion, moha: Skin Cream, moha: Hydrating Face Serum, moha: Sunscreen Spray. The details of these study test products are provided in (Table 1).

Table 1: Details of the products

These investigations involved adult participants spanning the age range of 18 to 65 years, encompassing diverse skin types such as sensitive, oily, dry, combination, and normal.

Materials and Methods

Study design and ethical consideration

The dermal safety studies were conducted at a single center and had a blinded dermal evaluator designated to assess the safety of the test products on healthy adult human subjects aged 18-65 years with varied skin types (oily, dry, normal and combination) and only sensitive skin for one test product. The studies adhered to ethical standards outlined by the Indian Council of Medical Research (ICMR), Good Clinical Practice (GCP) R2, the Declaration of Helsinki, and the method adhered to Bureau of Indian Standards (BIS), including PCD 19: Cosmetics (third revision) and IS 4011:2018 Methods of Test for Safety Evaluation of Cosmetics [8]. Additionally, compliance was ensured with CHD 25: Soaps and Other Surface-Active Agents Sectional Committee (first revision) and IS 13424:2001 Safety evaluation of bathing bars and toilet soaps [9].

Before commencing the study, a thorough review of essential documents, including the master Protocol (Version#01 - Final), Informed Consent Form (Version#01 - Final), Case Report Form (Version#01 - Final), Log-sheets (Version#01 - Final), protocol appendices were undertaken and approval from an Independent Ethics Committee (IEC) was successfully obtained. The studies were officially registered with the Clinical Trial Registry India (CTRI) except for few products (Table 2). Subjects provided written, informed consent before being enrolled in the study.

Table 2: Draize Scale for Irritation Scoring

Participation criteria

The subjects were pre-screened per inclusion and exclusion criteria. The female and male subjects aged 18-65 years having healthy skin (free of eczema, wounds, inflammatory scar) on the studies anatomic site with no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up were enrolled in the study. Subjects who had history of diabetes, asthma or Chronic obstructive pulmonary disease (COPD), skin disease including eczema, atopic dermatitis, lichen planus, vitiligo or active cancer and mastectomy involving removal of lymph nodes within past year, or treatment of any active type of cancer within the last 6 months or with known allergy to perfumes or any cosmetic products, plaster, food, having miliaria, too many naevus, or high pilosity on the back were excluded. For Sunscreen spray, additional criteria included the evaluation using Baumann’s questionnaire to identify the subjects with sensitive skin.

Patch application and removal of test products

Total 26 test products were tested in different studies along with the positive control i.e. 1% SLS solution and 3% SLS solution and negative control i.e. 0.9% isotonic saline solution. The description of the study products is shown in (Table 3). The test sites were cleaned with distilled water and water before the test product application.

Table 3. Study Test Products, Site Information with CTRI Registration Numbers

To apply the Sunscreen Spray, a 1cm 2 disc of Whatman number 3 filter paper was positioned on the subjects' backs. About 0.02mL or 20μL of the test product was carefully deposited onto the filter paper disc in a drop wise fashion, and the remaining 0.02ml or 20μL was similarly applied. After complete evaporation of the product, the whatman#3 filter paper was removed, and the site was left undisturbed for up to thirty minutes before proceeding to occlude the patch.

For rinse-off products including moha: Soap, moha: Rose and Almond Soap, moha: Scrub Soap, moha: Herbal Shower Gel, moha: Herbal Face Wash, moha: Herbal Shampoo, moha: Herbal Anti-Dandruff Shampoo, moha: Sulfate Free Herbal Shampoo, and moha: Herbal Hair Conditioner, 0.04 mL of 8% w/v solution of test samples in distilled water was dispensed onto the centre of an appropriately sized filter paper placed in the designated IQ/Finn chambers prefixed to a micropore tape and was applied onto the back of the subjects [Figure 1].

Figure 1 Draize Scale for Irritation Scoring.

Leave-On products i.e. moha: Herbal Scrub, moha: Aloe Vera Gel, moha: Rose Mist, moha: Herbal Lip Balm, moha: Herbal Sunscreen Lotion with SPF 50, moha: Moisturizing Lotion, moha: Rejuvenating Massage Oil, moha: Foot Care Cream, moha: Nail Care Cream, moha: 5 In 1 Hair Oil, moha: Anti- Dandruff Hair Oil, moha: Herbal Hair Serum, moha: Herbal Radiance Face Mask, moha: Overnight lotion, moha: Skin Cream, moha: Hydrating Face Serum were applied neat onto the filter paper and were applied on the subject’s back. Positive controls (1% SLS and 3% SLS) and negative control were applied in a similar fashion.

Single 24-hours application of test products along with positive and negative controls were kept in contact with the skin of subjects under complete occlusion for at least 24 hours (+2 hours). Subjects were informed to follow study instructions and were asked return to the facility on day-2 for the patch removal process followed by application site cleaning with distilled water to remove any residue of test products. Irritation scoring was done 30 minutes and 24 (+2 hours) post patch removal on day-2 and day-3 respectively.

Dermal irritation scoring post patch removal

The total study duration was 9 days from the patch application day. Application sites were evaluated for scoring the reaction, namely erythema, dryness, wrinkles on 0-4 points scale separately for each parameter and oedema on another 0-4 points scale as per Draize scale mentioned in (Table 4), after 3+5 minutes and 24±2 hours of patch removal as mentioned in Methods of test for safety evaluation of cosmetics, reaffirmed (2004), Bureau of Indian Standards, PCD 19: Cosmetics [Third revision and IS 4011:2018 Methods of Test for Safety Evaluation of Cosmetics]. Subjects were contacted telephonically after 168±2 hours of patch removal for any signs of erythema, dryness, oedema and wrinkles and confirmation for the same have been taken from the subjects.

Table 4. Products Description

The highest score of erythema, dryness and wrinkles were taken for calculation of Mean Irritation Score (MIS). Mean Score for Irritation = Total score (highest score from erythema, dryness, wrinkles + oedema) for each sample / total no. of subjects.

The determination of final results for test products, positive, and negative controls was based on the Mean Irritation Score (MIS) obtained, following the guidelines outlined in BIS: PCD 19: Cosmetics (third revision) and IS 4011:2018 Methods of Test for Safety Evaluation of Cosmetics, specifically in accordance with clause 4.3.1.3. The test products with mean score less than 2.0/8.0, 2.0-4.0/8.0, and above 4.0/8.0 were considered as non-irritant, mild irritant and irritant respectively.

Scoring of irritation was conducted using a 100-watt incandescent blue bulb lamp as the artificial light source to illuminate the patch areas. The light lamp was 1 ft distance away from application site. The scorer was blinded as to treatment assignments and any previous scores.

Statistical methods

Subjects’ demographic details were presented using descriptive statistics. For qualitative variables, frequencies and percentages were reported. Quantitative variables were summarized using means, medians, standard deviations, minimum and maximum values.

Results

The demographic characteristics of subjects such as gender, age, skin type was included in all the studies as shown in (Table 5).

Table 5: Demographic inclusive to Age and Skin Type Distribution of Enrolled Subjects

There were total of 26 cosmetics and personal care products tested where out of twenty skin care products there was one face wash, one scrub, one gel, one mist, one lip balm, three lotion, three soap, one shower gel, one massage oil, one foot care cream, one nail care cream, two serum, one face mask, one cream, one sunscreen spray that included moha: Herbal Face Wash, moha: Herbal Scrub, moha: Aloe Vera Gel, moha: Rose Mist, moha: Herbal Lip Balm, moha: Herbal Sunscreen Lotion with SPF 50, moha: Moisturizing Lotion, moha: Soap, moha: Rose And Almond Soap, moha: Scrub Soap, moha: Herbal Shower Gel, moha: Rejuvenating Massage Oil, moha: Foot Care Cream, moha: Nail Care Cream, moha: Herbal Hair Serum, moha: Herbal Radiance Face Mask, moha: Overnight Lotion, moha: Skin Cream, moha: Hydrating Face Serum, moha: Sunscreen Spray and 6 hair care products i.e. two hair oil, three shampoo, one conditioner including moha: 5 In 1 Hair Oil, moha: Anti- Dandruff Hair Oil, moha: Herbal Shampoo, moha: Herbal Anti-Dandruff Shampoo, moha: Sulphate Free Herbal Shampoo, moha: Herbal Hair Conditioner, had mean irritation score less than 2.0 and hence were found to be nonirritant and safe on skin. The negative control with mean irritation score less than 2.0 and positive control with mean irritation score more than 2.0 had been found to be non-irritant and irritant respectively (Table 6).

Table 6: Mean Irritation Scores [MIS] for Each Tested Formulation

Images of 30 minutes and 24 hours post patch removal have been shown in [Figure 2].

Figure 2 Images at 30 minutes and 24 hours Post Patch Removal.

Safety Assessments

Adverse events

Throughout the study, no adverse events were reported by any of the subjects, leading to the conclusion that the products were safe for use and well-tolerated.

Discussion

The human skin is a very good barrier that is protective against environmental factors and different chemicals present in pharmaceutical formulations and cosmetic products. Evaluation of the skin irritation and/or corrosion potential of the ingredients of a cosmetic product is necessary in order to assess its toxic effects and safety. Skin irritation can be seen after dermal use of cosmetic and personal care products. Other than skin irritation, allergic reactions and acne can also be seen after the use of cosmetics. Evaluating the skin irritant and/or corrosive properties of the end product can also be helpful in describing the potential hazard [10].

Numerous studies have highlighted that skincare products, including moisturizing and cleansing cream, lotion, are frequently implicated in cases of contact allergy to cosmetics. However, drug patch tests can be particularly valuable in identifying the specific ingredient or drug associated with various medical conditions. Soaps and shampoos are the most important types of cosmetics responsible for adverse reactions [11]. In this conducted study the cosmetic products including skin care and hair care products were tested for irritation potential and were found to be safe and non-irritant in nature on the study population. It is highly recommended that the cosmetic companies test the cosmetic product’s ingredient for skin irritation potential before they market them but unfortunately, these end-product testing are not usually performed by the cosmetic companies. The regulatory authority should encourage these testing before providing permission to market the products to be used by the population.

Further, natural personal care products have proven to be safe to use than conventional beauty products. Dermatologists have tested and confirmed that they are hypo-allergenic and safe to use, since they do not cause problems like skin rashes or itchy skin. Parabens, the most common preservative in cosmetics, penetrate the skin, and are suspected of disrupting hormone function. Herbal products do not contain parabens. All skin types can use natural personal care products [12].

However, not all products marketed as being natural are equally safe to use. Since cosmetic product labelling regulations are lax, a product labelled as "natural" may contain undesirable synthetic chemicals, on top of the natural ingredients. Also, pesticides and other harmful chemicals may have been applied to the raw natural procurements that were used to make a "100% natural" personal care product [13]. Vedistry’s Moha range of skin and hair care products are all regular synthetic with herbal actives.

Conclusion

In summary, the dermal safety assessments conducted on Vedistry’s moha range skincare and haircare products formulated with natural ingredients, including Moha: Herbal Face Wash, moha: Herbal Scrub, moha: Aloe Vera Gel, moha: Rose Mist, moha: Herbal Lip Balm, moha: Herbal Sunscreen Lotion With SPF 50, moha: Moisturizing Lotion, moha: Soap, moha: Rose And Almond Soap, moha: Scrub Soap, moha: Herbal Shower Gel, moha: Rejuvenating Massage Oil, moha: Foot Care Cream, moha: Nail Care Cream, moha: 5 In 1 Hair Oil, moha: Anti-Dandruff Hair Oil, moha: Herbal Shampoo, moha: Herbal Anti-Dandruff Shampoo, moha: Sulfate-Free Herbal Shampoo, moha: Herbal Hair Conditioner, moha: Herbal Hair Serum, moha: Herbal Radiance Face Mask, moha: Overnight Lotion, moha: Skin Cream, moha: Hydrating Face Serum, and moha: Sunscreen Spray, affirm their nonirritating nature with skin compatibility and safety for diverse skin types-ranging from oily and mixed to dry, normal, and sensitive.

Conflict of Interest

Dr. Ipsa Pandya and Dr Raji Patil affirms that they have no conflicts of interest regarding providing scientific insights and designing the clinical study. Dr Manisha Mishra is an employee of Vedistry Private Limited. Dr Nayan and Maheshvari Patel were part of scientific writing have no conflict of interest. The authors declare that any association have not influenced the work reported in this paper.

Acknowledgements

The authors would like to express their gratitude to Dr Nayan Patel (MBBS), Ms. Maheshvari Patel (PhD Scholar, Pharmacology) and Megha Yadav (MSc. Clinical Research) for their valuable support in the preparation of this manuscript. Additionally, we sincerely thank to study Investigator(s) and study staff of Cliantha Research and Mscot SpinControl Private limited for participation of the study as clinical researcher and all the subjects who participated in this study for their contribution.

Funding: Study was funded by Vedistry Private Limited, Mumbai, Maharashtra, India

Ethical Approval: Yes, the studies were approved by the Independent Ethics Committees.

CTRI Registration: Yes, refer Table#2.

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