Reason for request


Key points

Re-evaluation of all oral isotretinoin-based proprietary medicinal products indicated for the treatment of severe acne:

Retention of approval for reimbursement for the marketing authorisation indication.

Role in therapeutic strategy?

The medication arsenal includes topical and systemic treatments, combined with appropriate hygiene care. The choice of treatment will depend on the severity of the acne.

According to the SFD, an initial treatment is prescribed as a first-line treatment for a period of three months, with the aim of obtaining a significant reduction or disappearance of the lesions and preventing the occurrence of scarring. After three months, the effectiveness of the treatment is reassessed, and if it fails, a second-line treatment is implemented. Local treatments, whether creams or gels, based on benzoyl peroxide and retinoids are preferable, alone or in combination, as a first-line treatment for very mild (GEA grade 1) to moderate (grade 3) acne. In the event of failure after three months, the recommended second-line treatments are:

  • Grade 1 acne: a combination of benzoyl peroxide and local retinoids;
  • Grade 2 acne: intensification of local treatment, or a combination of first-line treatment with oral antibiotics (cyclin), or a combination of local retinoids or azelaic acid with local antibiotic therapy;
  • Grade 3 acne: oral isotretinoin;
  • Grade 4 acne: oral isotretinoin (treatment can be initiated prior to three months if there is a high risk of scarring or in the event of recurrence).

For highly inflammatory grade 5 acne with nodules covering the face, oral isotretinoin is prescribed as the first-line treatment.

After remission, local maintenance treatment (adapalene or adapalene + benzoyl peroxide, or even tretinoin instead of adapalene) should be prolonged as long as necessary to prevent relapse.

An oestrogen-progestin therapy for contraceptive purposes may be administered to women with acne, regardless of its severity.

Role of proprietary medicinal products assessed in the therapeutic strategy

Oral isotretinoin-based proprietary medicinal products (ACNETRAIT, CONTRACNE, CURACNE and PROCUTA) continue to play a role in the treatment of severe acne (such as nodular acne, acne conglobata or acne likely to lead to permanent scarring) that is resistant to appropriate courses of conventional therapy (for three months, with good compliance) involving systemic antibiotics and topical treatment.

Due to the adverse effects observed with isotretinoin, and because of the risk of teratogenicity in particular, it is essential for the recommendations associated with its prescription to be followed [see SPC, Pregnancy Prevention Programme (PPG) and Risk Management Plan (RMP)].

The use of this medicine is contraindicated in pregnant or breastfeeding women (see SPC).




Clinical Benefit


The Committee deems that the actual clinical benefit of oral isotretinoin-based proprietary medicinal products (ACNETRAIT, CONTRACNE, CURACNE and PROCUTA) is substantial in the marketing authorisation indication.


Clinical Added Value

Not applicable

Sans objet.

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