Background and Importance Chronic graft-versus-host disease (cGVHD) is an important late complication after allogeneic haematopoietic stem cell transplant (HSCT). The skin is usually the first and most affected organ involved in cGVHD and topical steroids are one of the most commonly used drugs for this affection.¹

Aim and Objectives A 3-year-old boy was diagnosed with acute myeloid leukaemia in 2019 and, after HSCT, manifested cutaneous cGVHD. The hospital pharmacy service was asked to develop a paediatric magistral formula of topical ointment based on clobetasol 0.015% in petrolatum.

Material and Methods A scientific literature search was conducted. Galenic development and validation of the formula were described in the monograph ‘Semi-solid preparations for cutaneous application’ of the Official Pharmacopoeia of the Italian Republic.

A topical magistral formula of clobetasol ointment 0.015% in petrolatum was developed, to be administered once daily on lesions. The efficacy of the formulation was evaluated by the physician. Skin therapy also included a moisturising lotion and almond oil.

Results The development was based on a case series of oral cGVHD in which a hydrophilic gel formulation was used successfully. Clobetasol has been shown to have higher potency and the highest level of evidence.

In contrast to the hydrophilic gel, the 0.015% clobetasol ointment preparation was formulated on petrolatum to allow for superior skin permanence, starting with low concentrations of clobetasol as the patient aged. Petrolatum forms an occlusive, hydrophobic layer on the skin, physically blocking transedermal water loss and creating increased skin hydration for more than 4 hours.

A shelf life of 30 days has been established, based on the critical skin injury in this paediatric patient. Odour, colour and phase separation remained stable during the month.

The patient well tolerated the treatment, and the doctor confirmed, after four months of treatment, the improvement of the skin lesion. The paediatric patient, after the described improvement, discontinued the clobetasol ointment.

Conclusion and Relevance Clobetasol ointment 0.015% is a good therapeutic solution in paediatric patient with cGVHD, expecially for its pharmaceutical formulation.

References

1. Kim YJ, et al. Evidence-based, skin-directed treatments for cutaneous chronic graft-versus-host disease. Cureus 2019 Dec 25;11(12):e6462. doi:10.7759/cureus.6462.PMID:32025391;PMCID:PMC6977575.

2. Ghadially R, et al. Effects of petrolatum on stratum corneum structure and function, JAAD 1992;26(3):387–396. ISSN 0190-9622, https://doi.org/10.1016/0190-9622(92)70060-S.

Conflict of Interest No conflict of interest