Isotretinoin 5mg capsules (once daily) in the treatment of persistent low grade adult acne.
Randomized, double-blind, placebo-controlled, parallel group clinical study of Isotretinoin 5 mg capsules (once daily) in the treatment of persistent low grade adult acne for 16 weeks followed by an open-label phase of 16 weeks - Protocol Number: ZPS-365
Douglas Pharmaceuticals Ltd
60 participants
Aug 18, 2008
Interventional
Conditions
Summary
Isotretinoin is a retinoid, structurally related to vitamin A, which has been used orally in human medicine for more than 20 years in the treatment of severe acne resistant to other treatments. A large body of published data, from both human and animal studies, suggests that the clinically useful action of isotretinoin is to reduce both the size and secretory capacity of sebaceous glands. Although isotretinoin has no significant in vitro antibacterial activity, when used orally to treat acne it causes a significant reduction in the numbers of skin bacteria. This effect is generally believed to be secondary to its action in reducing sebum production and may contribute to its useful action in treating acne. Some recent publications suggest lower doses of isotretinoin may be a useful alternative for patients who present with less severe acne. The clinical efficacy of treating specific patient groups with a daily low dose alternative to complicated periodic or interrupted dose schedules with higher strength capsules needs further investigation.
Eligibility
Plain Language Summary
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Interventions
Patients are randomised to receive orally one Isotretinoin 5 mg capsule daily for 32 weeks or placebo for 16 weeks followed by one Isotretinoin 5 mg capsule daily for 16 weeks. A 10 week follow-up period for all patients occurs at the completion of the treatment phase.
Locations(1)
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ACTRN12612000062820