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How effective and safe is isotretinoin when taken in tablet form by people with acne? We reviewed the evidence on the effects of isotretinoin when administered either with itself at a different dose, with placebo (an identical but inactive treatment), or with other systemic (oral or injected drugs that act throughout the body) or topical (on the Applied to the skin). In the case of eligible participants, acne had to be diagnosed by a doctor.


Acne is a persistent inflammatory condition that can affect over 80% of teenagers. Acne (which includes blackheads and pimples) occurs primarily on the face, but it can also affect the back and chest. Mental health problems, depression, and suicidal thoughts have been linked to acne. Isotretinoin, a currently widely used therapy derived from vitamin A, has changed the way we treat acne. However, it can cause undesirable effects and has been linked to as yet unclear psychiatric events and chronic inflammatory bowel disease.

Study characteristics

We searched the medical literature through July 2017 and included 31 studies involving a total of 3,836 dermatology outpatients worldwide. Twice as many men as women took part; Their ages ranged from 12 to 55 years. The severity of the acne ranged from mild to severe, although most of the participants had severe acne.

The pharmaceutical industry funded 12 of the included studies.

We found studies comparing oral isotretinoin with placebo or other treatments such as antibiotics. In addition, different dosages, treatment plans or compositions of oral isotretinoin and oral isotretinoin with additional topically applied active ingredients were evaluated.

Main results

Three studies compared oral isotretinoin with oral antibiotics and additional topically applied agents given to participants with moderate or severe acne for 20 to 24 weeks. The endpoints were measured immediately after the end of treatment.

There was no difference between therapies in reducing the number of inflammatory lesions (an area of ​​an organ or body tissue that has been damaged by disease or trauma). In one participant, isotretinoin led to the development of Stevens-Johnson syndrome (a serious condition in which the skin reacts violently, often in response to medication). There were no serious side effects in the other group. However, we are unsure about these results because they are based on very low quality evidence.

When assessed by a doctor, isotretinoin might improve acne severity somewhat, but it could trigger more side effects, such as sore lips, dry skin, or nausea (low-quality evidence).

Fourteen studies compared different dosages / treatment plans of oral isotretinoin for 12 to 32 weeks. Most of the participants had severe or moderate acne.

Two studies, each comparing three different doses of isotretinoin after 20 weeks, found greater improvement (as measured by the number of inflammatory lesions) with the higher dose (low-quality evidence). A third study showed that ongoing (daily) low dosing and ongoing (daily) conventional dosing were more likely to improve acne than intermittent (not regularly, only at certain time periods) therapy, measured after 24 weeks (low quality evidence). The conventional dosage of isotretinoin reduced the number of inflammatory lesions rather than the low dosage. However, this is based on very low quality evidence indicating uncertainty.

During treatment (between 12 to 32 weeks) or post-treatment follow-up (up to 48 weeks), no serious side effects occurred in 14 studies of different doses of isotretinoin (low-quality evidence). The severity of the acne as measured by the doctor was not examined in this comparison. Less severe side effects (including dry skin, hair loss, and itching) were looked at in 13 studies. However, we are unsure whether there were any differences between the groups (evidence from very low to low quality when examined).

No study reported birth defects.

Quality of the evidence

Overall, the quality of the evidence was low for all of our main endpoints due to severe limitations in study design and the limited amount of data. The established place of oral isotretinoin in acne treatment is therefore neither supported nor contested by the clinical studies found.