Publication:

Evaluation of effectiveness and tolerability of a moisturiser as an adjuvant to isotretinoin therapy for acne: a real-world evidence

Background Moisturizers are recommended as an adjuvant to acne therapies especially topical/systemic retinoids to counteract their cutaneous side-effects. Moisturisers also reduce inflammation and the intensity of acne. The compliment study was designed to evaluate effectiveness and tolerability of moisturiser (Excela, Cipla Ltd., Mumbai, India) in patients prescribed isotretinoin for managing their acne in real-world scenario.

Methods This open-label, observational, prospective, non-comparative multicentre study was conducted between June 2019 and January 2020. Patients who were prescribed Excela moisturiser as an adjuvant to isotretinoin for acne management were enrolled. After four weeks, the investigator graded the patient’s skin on smoothness and softness on a five-point scale and dryness, scaling and redness on a four-point scale. Its organoleptic characteristics and tolerability were evaluated using the subject assessment questionnaire.

Results We enrolled 200 patients (average age: 24.02±5.44 years). Investigators rated smoothness and softness of the skin as very good to excellent in 129 (64.5%) and 113 (56.5%) patients. No patient reported severe skin dryness, scaling or redness. Very good to excellent spreadability and appeal was rated by 132 (66.0%) and 133 (66.5%) patients, respectively. Eighty (40%) patients rated the moisturiser as non-greasy/non-sticky. Itching (1%), redness (0.5%), cold (0.5%), and cough (0.5%) were reported as adverse events but were of mild intensity and unrelated to the study product. No patient experienced serious adverse event or moisturiser-related adverse event.

Conclusions Overall, Excela moisturiser was effective and tolerable in patients with acne who were prescribed isotretinoin at the end of 4-week-long treatment period.