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ENCAPSULATED BENZOYL PEROXIDE: NOVEL FORMULATION FOR ROSACEA

Author: Medical Team

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BACKGROUND

In a new study published in SKIN - JOURNAL OF CUTANEOUS MEDICINE, researchers found out that Benzoyl peroxide (E-BPO) 5% encapsulated with silica gel is clinically effective for the treatment of inflammatory lesion occurring in rosacea. This first-ever encapsulated formulation of benzoyl peroxide first received approval from FDA on 25 April, 2022.

 

ABOUT ROSACEA

Rosacea is a long-term inflammatory skin disorder characterized by facial erythema, flushing, papules, pustules, phymas, and telangiectasias. It primarily affects the cheeks, nose, chin, forehead, and eyes. The occurrence of rosacea is more prevalent in people with fair skin from celtic and northern European descent. One study reported that rosacea account for almost 0.5% of all dermatology consultations in India indicating its commonness than what is perceived for Indian population.

Current treatment options for rosacea include lasers, OTC products containing azelaic acid and sulfur, however these treatments lack efficacy in the treatment of inflammatory nodules associated with rosacea and there is an issue of lack of patient compliance with the use of technology like laser. 

In such scenario Encapsulated benzoyl peroxide is a novel product with better efficacy and tolerability profile, and can be used in patients that are not satisfied with the other treatment options.

 

WHAT MAKES ENCAPSULATED BENZOYL PEROXIDE BETTER?

Microencapsulation creates a shell of silicon dioxide between Benzoyl peroxide & skin, and thus controls the release of benzoyl peroxide to improve its tolerability. This allows the use of benzoyl peroxide in more sensitive and dry skin.

 

   

 

Microencapsulation

 

STUDY CHARACTERISTICS

  • Both studies were Phase 3, Double-blind, Randomized and Vehicle-controlled, conducted in both men and women of age   ≥ 18 years with moderate to severe rosacea and ≥15 to ≤70 inflammatory lesions as clinical feature. The subjects included in the study had global assessment score of 3 or 4.
  • The subjects were to apply either apply E-BPO (Encapsulated Benzoyl Peroxide Cream) or 5 % E-BPO cream once daily for 12 weeks.
  • The primary endpoint of the study was a measure of success i.e., “clear” (0) or “Almost clear” (1) as per the Investigator Global Assessment (IGA) scale at 12th week of treatment. The secondary endpoint was percentage change and absolute change in the inflammatory lesion count at week 12 and 8 respectively from baseline

                                   Investigator Global Assessment (IGA) scale

                                                                                                                                               

     Grade

                                           Description

      0 - Clear

   Skin clear of inflammatory papules or pustules

    1 - Almost Clear

   Presence of very few small papules/ pustules and very mild dull erythema

    2 - Mild

   Presence of few small papules / pustules and very mild dull erythema

    3 - Moderate

   Several to many small or larger papules or pustules and moderate light to         bright red erythema are present

    4 - Severe

  Numerous small and/or larger papules or pustules and severe erythema that is bright red to  deep red are present

 

RESULTS

  • In both studies 5% E-BPO cream demonstrated significant improvement on primary endpoint whereas E-BPO demonstrated significant reduction in the inflammatory lesions count at week 12 when compared with vehicle. 
  • In each 12-week study, reduction in mean inflammatory count was seen within week 2 which was maintained till week 12.
  • 5 % E-BPO cream was well tolerated and the side effects of both  intervention were mild.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONCLUSION

Treatment with encapsulated benzoyl peroxide (5%) is superior to vehicle in the treatment of inflammatory lesions of rosacea.  People with rosacea experience a significant burden of this disease and have diminished quality of life. Hence, approval of such a novel formulation is an important advancement for the people living with rosacea worldwide.

 

REFERENCE

  1. Del Rosso, J., Sugarman , J., Gold, M., Arekapdui, K., & Green, L. (2022). A New Frontier in Acne Treatment: Encapsulated Benzoyl Peroxide and Tretinoin. SKIN The Journal of Cutaneous Medicine, 6(2), s16. https://doi.org/10.25251/skin.6.supp.16
  2. Van Zuuren, E. J., Arents, B., van der Linden, M., Vermeulen, S., Fedorowicz, Z., & Tan, J. (2021). Rosacea: New Concepts in Classification and Treatment. American journal of clinical dermatology, 22(4), 457–465. https://doi.org/10.1007/s40257-021-00595-7

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