A novel emollient plus significantly improves skin condition and pruritus in contact dermatitis

Contact dermatitis is a frequent inflammatory dermatosis characterized by erythematous, pruritic lesions occurring after exposure to an exogenous agent. Two main entities are distinguished: irritant contact dermatitis, driven by direct non-immunological cutaneous inflammation, and allergic contact dermatitis, a T cell-mediated delayed hypersensitivity reaction that occurs upon re-exposure. Clinical features include erythema, scaling and pruritus; acute cases may present with vesicles/bullae, whereas chronic disease may lead to lichenification and fissuring.¹

This study aimed to evaluate the tolerance and effectiveness of a balm emollient plus (containing active ingredients) on discomfort (including pruritus) and overall skin condition in adults with contact dermatitis.

[1] Usatine RP, Riojas M. Diagnosis and management of contact dermatitis. Am Fam Physician. 2010 Aug 1;82(3):249-55. PMID: 20672788.

This single-centre, open-label clinical study conducted under dermatological supervision included 32 adults (19-65 years old) with allergic (n=15) or irritant (n=17) contact dermatitis. Participants had Fitzpatrick phototypes III-V and diverse ethnic backgrounds (Caucasian 13%, Asian 3%, Indian 25%, African 44%, mixed 16%). In half of the participants, disease onset was >6 months before inclusion. Participants with allergic contact dermatitis had used topical corticosteroids prior to inclusion but remained symptomatic, supporting study eligibility.

At visit 1 (D0), participants refrained from applying skincare products other than routine hygiene. After acclimatization, a dermatologist evaluated affected areas (face and/or body), scoring clinical signs (xerosis and roughness; 0-9 scale) and disease extent (palm units). Participants self-assessed functional symptoms (discomfort, pruritus, intensity of urge to scratch, and impact on daily activities) using 0-9 scales and an 11-point numerical rating scale (NRS, 0-10). The investigational emollient and a daily log were provided for home use.

On D7, participants repeated the functional symptom self-assessments at home.

At visit 2 (D28), compliance was checked and clinical and self-assessments were repeated. Adverse events, concomitant treatments and product tolerance were recorded using investigator evaluation and a participant self-administered questionnaire.

Over 28 days, participants applied the balm to affected areas a mean of twice daily. Dermatologist-assessed skin condition improved markedly by D28, with statistically significant reductions in xerosis (-73%), roughness (-71%) and extent of affected areas (-73%) (each with p<0.001 versus D0).

Functional symptoms improved significantly as early as D7, with further gains by D28. Discomfort decreased by -76% at D7 and -91% at D28; pruritus by -70% and -89%; and urge to scratch by -73% and -88%, respectively (each with p<0.001 versus D0). Consistently, limitations in work and personal activities due to itching decreased by -71% at D7 and -91% at D28 (each with p<0.001 versus D0).

The product was very well tolerated and was highly appreciated.

In this open-label study in adults with irritant or allergic contact dermatitis, twice-daily use of a balm emollient plus for 28 days was well tolerated and associated with substantial improvements in clinician-rated skin condition and patient-reported symptoms, particularly pruritus and urge to scratch, with a concomitant reduction in daily activity impairment. These findings support this balm emollient plus as a useful adjunctive skincare option for contact dermatitis-related skin impairment and discomfort.