Information intended for healthcare professionals only.

This formulary decision guide was developed from content provided by Galderma UK Ltd in a format developed by Guidelines in Practice. Galderma UK Ltd carried out full medical approval to ensure compliance with regulations.

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Key points

Epiduo® 0.3%:

  • is a new drug/line extension, once-daily topical, combination product, for the treatment of patients with moderate-to-severe acne1
  • is a fixed-dose combination therapy with adapalene and benozyl peroxide that treats multiple pathogenic factors of acne1
  • is an antibiotic-free treatment.1

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Drug name

  • Epiduo® 0.3% (adapalene 0.3%/benzoyl peroxide 2.5% gel)

Indication

  • Epiduo® 0.3% is indicated for the cutaneous treatment of Acne vulgaris when comedones, numerous papules, and pustules are present1
  • Epiduo® 0.3% is indicated for patients >12 years old.

Dosage and administration

  • Epiduo® 0.3% is used to treat moderate-to-severe acne1
  • Epiduo® 0.3% is a white to very pale yellow opaque gel1
  • Epiduo® 0.3% should be applied once a day in the evening to the entire acne affected areas of the face and the trunk on clean and dry skin.

Mode of action

  • Epiduo® 0.3% combines two active substances, which act through different, but complementary, mechanisms of action1
  • Adapalene—it is a chemically stable, naphthoic acid derivative with retinoid-like activity—current evidence suggests that topical adapalene normalises the differentiation of follicular epithelial cells resulting in decreased microcomedone formation1
  • Benzoyl peroxide—it has been shown to have antimicrobial activity and is recognised as a very effective broad-spectrum antibacterial agent in the treatment of acne vulgaris1
  • Epiduo® 0.3% contains the highest available strength of adapalene (0.3%)1
  • Adapalene and Benzoyl Peroxide complementary mode of action targets three out of four factors responsible for the development of acne without the risk of antibiotic resistance.2–8 

Guideline recommendations

  • The Primary Care Dermatology Society (PCDS) provides information for grading acne based on lesion type to help guide treatment9
  • Epiduo® 0.3% provides:9
    • strong recommendation for pustules
    • moderate recommendation for comedones and papules.

Evidence of Use

  • Over a third of patients suffer from moderate-to-severe acne10
  • Patients treated with Epiduo® 0.3% reported high treatment satisfaction by achieving success in more than three times as many moderate-to-severe patients with acne versus vehicle at week 1211
  • More than three times as many patients were ‘clear’ or ‘almost clear’ of acne with Epiduo® 0.3% versus vehicle at week 2412
  • Epiduo® 0.3% reduces inflammatory lesions by 87% compared with baseline at week 2412
  • Over 80% of patients with severe acne were no longer candidates for oral isotretinoin (and therefore, did not need referral to, and follow up in, secondary care) following 12 weeks of Epiduo® 0.3% plus oral doxycycline treatment.13 

Adverse reactions

  • Common (≥1/100 to <1/10)—atopic dermatitis, eczema, skin burning sensation, and skin irritation1
  • Uncommon (≥1/1000 to <1/100)—erythema of eyelid, parasthesia, dry skin, pruritus, and rash1
  • Not known—eyelid oedema, anaphylactic reaction, throat tightness, dyspnea, allergic contact dermatitis, swelling face, pain of skin (stinging pain) and blisters (vesicles), skin discolouration (hyperpigmentation or hypopigmentation), urticaria, and application site burn.

Patient satisfaction

  • Nine of out ten patients:
    • were satisfied with their treatment with Epiduo® 0.3% versus vehicle12
    • adhered to the study treatment11
    • would use Epiduo® 0.3% again13
    • were satisfied with how quickly the treatment worked.12 

How to use Epiduo®

  • Instruct the patient to follow the steps detailed below when using Epiduo® 0.3% gel:14
    • Step 1: make sure the skin is clean and dry before application
    • Step 2: apply a thin layer of gel evenly over each of the areas affected by acne, ideally before bedtime
    • Step 3: wash your hands thoroughly
  • If the patient does not see any improvement after four to eight weeks then advise them to notify the healthcare professional.14 

Precautions

  • Advise the patient to not apply Epiduo® 0.3% gel to damaged skin, either broken (cuts or abrasions), sunburn, or eczematous skin1
  • Epiduo® 0.3% gel should not come into contact with the eyes, lips, mouth, nostrils, or mucous membranes. If the product enters the eye, the patient should wash it immediately with warm water1
  • If any reaction occurs suggesting any sensitivity to any component of the Epiduo® 0.3% gel, advise the patient to stop using and notify the healthcare professional.

References

  1. Galderma Ltd. Epiduo 0.3%/2.5% gel – summary of product characteristics. www.medicines.org.uk/emc/product/11180 
  2. Leyden J, Stein Gold L, Weiss J. Dermatol Ther (Heidelb). 2017; 7 (3): 293–304.
  3. Thielitz A, Sidou F, Gollnick H. J Eur Acad Dermatol Venereol. 2007; 21 (6): 747–753.
  4. Michel S, Jomrad A, Démarchez M. Br J Dermatol. 1998; 139 (Suppl 52): 3–7.
  5. Tenaud I, Khammari A, Dreno B. Exp Dermatol. 2007; 16 (6): 500–506.
  6. Canavan T, Chen E, Elewski B. Dermatol Ther (Heidelb). 2016; 6: 555–578.
  7. Cunliffe W, Holland K, Bojar R, Levy S. Clin Ther. 2002; 24 (7): 1117–1133.
  8. Sagransky M, Yentzer B, Feldman S. Expert Opin Pharmacother. 2009; 10 (15): 2555–2562.
  9. Primary Care Dermatology Society. Acne: acne vulgaris. www.pcds.org.uk/clinical-guidance/acne-vulgaris (Accessed July 2020).
  10. Tan JK, Bhate K. Br J Dermatol. 2015; 172 (Suppl 1): 3–12.
  11. Stein Gold L, Weiss J, Rueda M et al. Am J Clin Dermatol. 2016; 17: 293–303.
  12. Dréno B, Bissonnette R, Gagné-Henley A et al. Am J Clin Dermatol. 2018; 19: 275–286.
  13. Del Rosso J, Stein Gold L, Johnson S. J Drugs Dermatol. 2018; 17 (3): 264–273. 
  14. Galderma. Epiduo 0.3%/2.5% gel – patient leaflet. www.medicines.org.uk/emc/product/11180/pil

EFO20-05-0097b

Date of preparation: September 2020