Open-label and single-arm clinical study to evaluate the efficacy and safety of EqualsTwo® skin healing cream in mild-to-moderate eczema

Kinjal Barot; Dhruv Zaveri; Trupti Patel; Parth Joshi; Simran Sethi; Sunil S. Iyer; M. E. Kannan

doi:10.18203/2319-2003.ijbcp20261955

Authors

Kinjal Barot Zydus Lifesciences Limited, Pharmaceutical Technology Centre (PTC), Sanand, Ahmedabad, Gujarat, India
Dhruv Zaveri Zydus Lifesciences Limited, Pharmaceutical Technology Centre (PTC), Sanand, Ahmedabad, Gujarat, India
Trupti Patel Zydus Wellness Centre, Ahmedabad, Gujarat, India
Parth Joshi Cliantha Research Limited, Ahmedabad, Gujarat, India
Simran Sethi Cliantha Research Limited, Ahmedabad, Gujarat, India
Sunil S. Iyer Zydus Lifesciences Limited, Pharmaceutical Technology Centre (PTC), Sanand, Ahmedabad, Gujarat, India
M. E. Kannan Zydus Lifesciences Limited, Pharmaceutical Technology Centre (PTC), Sanand, Ahmedabad, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20261955

Keywords:

Atopic dermatitis, Eczema, Plant preparations, Skin barrier, Dermatitis, Infantile

Abstract

Background: Atopic dermatitis (AD) is a chronic relapsing inflammatory dermatosis with substantial clinical and psychosocial burden. Safety concerns and poor adherence with corticosteroids and calcineurin inhibitors have increased interest in non-steroidal, plant based topical alternatives. This study aimed to evaluate the efficacy, tolerability, and patient-reported acceptability of EqualsTwo^® Skin Healing Cream (Investigation product), a coconut-based emollient with botanical extracts in infants, children, and adults with mild-to-moderate eczema.

Methods: A 14-day open-label, single-arm, single-center study enrolled 58 participants (39 infants/children; 19 adults). Primary endpoints were the three-item severity (TIS) score (pediatric) and eczema area and severity index (EASI) score (adults). Secondary endpoints included Mexameter® MX 18 erythema assessment, skin pH measurement, dermatologist/pediatrician skin evaluations, and structured patient/parent-reported questionnaires. Nonparametric and paired statistical analyses were performed (significance: p<0.05).

Results: At day 14, adult EASI and pediatric TIS scores improved by 30.9% and 79.7%, respectively (both p<0.0001). Secondary outcomes showed a 7.6% erythema index reduction, modest pH normalization, and consistent improvements in dryness, pruritus, and irritation, with universal patient/parent satisfaction and no hypersensitivity reactions. Limitations include the uncontrolled open-label design, short duration, small sample (n=58), single-center recruitment, mild-to-moderate disease scope, and absence of validated quality-of-life or objective barrier function measures.

Conclusions: EqualsTwo^® skin healing cream demonstrated statistically significant improvements in disease severity and symptom burden across pediatric and adult AD populations, with excellent tolerability and no adverse reactions. These findings support its potential as a safe, non-steroidal adjunct emollient therapy.

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