12 June 2020
Medicine Compliance Aid Stability
genericActavis UK Ltd
Actavis UK Ltd
Tablets 50mg, 100mg
A3 · Amber 3 No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from moisture
Protect from moisture and light.
20 April 2015
Lactation Safety Information
Alternative microbiologically appropriate antibacterial
Limited published evidence of safety
Significant amounts in breast milk
Haemolytic anaemia reported in one infant
Avoid in known G6PD deficiency, hyperbilirubinaemia, and in jaundiced premature infants because of risk of kernicterus
23 September 2020
Aczone (US)Acne vulgaris
Development and Regulatory status
Dec 19Launch in UK appears unlikely .
Sep 19Launched in the US for treatment of acne in children aged 9 to 11 years; this was based on data from a Phase IV trial (NCT02959970) .
Feb 16FDA announce approval of a new 7.5% concentration of dapsone (ACZONE) gel for topical treatment for acne in patients 12 years of age and older .
Tetrahydrofolate dehydrogenase inhibitor formulated as a topical 5% and 7.5% gel formulation of the antibacterial dapsone using Solvent-Microparticle (SMP™) delivery technology 
Moderate-to-severe acne affects about 20% of young people .
Trial or other data
Nov 14PIII NCT01974141 & NCT01974323 complete .
Nov 13NCT01974141 and NCT01974323 are two PIII studies of dapsone gel vs vehicle control each in 2180 patients with acne vulgaris. The primary outcomes are % of patients with none or minimal on the 5-point Global Acne Assessment Score (GAAS) Scale and change from baseline in inflammatory and noninflammatory facial lesion counts, all at 12 weeks. The studies start Nov 13 and are due to complete May 15