ACNE-ID
Research type
Research Study
Full title
Investigating the benefits and harms of reduced daily dose oral isotretinoin in the treatment of acne: A parallel group, assessor blind, non-inferiority, multicentre randomised controlled trial, with an internal pilot
IRAS ID
1009472
Contact name
Esther Burden-Teh
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN45540647
Research summary
Although many teenagers experience acne, around 1 in 10 of people get severe acne that can scars their skin. Having acne on your face and body as a young person can affect your confidence, sometimes leading to low mood and anxiety. However, there is a very effective treatment for severe acne called isotretinoin. Although isotretinoin works well at clearing acne at this dose, nearly everyone (8 in 10) experience side effects such severe drying of the lips, skin and lining of the nose. Other side effects can occur including aching muscles and tiredness (2 in 10) and acne flares when starting treatment (2 in 10). Isotretinoin can also harm an unborn child which is why strict contraception (e.g. combined oral contraceptive pill and condoms) is needed during treatment.
One way to reduce these side effects is to give a lower dose of isotretinoin possibly over a longer period of time. But we want to be sure a lower dose clears acne as well as the standard dose, and if people are happy to take the tablets for a longer time. It is also possible that if the acne is not fully treated at a lower dose, it will come back soon after stopping treatment.
The current standard dose of isotretinoin is ≥0.5mg per kg daily, the low dose for the trial is around half the dose 0.25mg per kg daily. Participants in standard dose group will have the dose increased throughout the treatment course. It is expected that participants on the lower dose will likely take the tablets for longer than participants on the standard dose.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0111
Date of REC Opinion
1 Aug 2024
REC opinion
Further Information Favourable Opinion