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
Inclusion Criteria6
- Male or female aged between 25 and 55 years at the time of randomization.
- If the participant is female, she should be either: post menopausal for at least 1 year, surgically sterile for at least 3 months, stable on hormonal contraceptives for at least 6 months and agree to continue these during the study and for 30 days after treatment completion, or be willing to use double-barrier contraception for the duration of the study and for 30 days after treatment completion.
- Two or more acne lesions/month for at least the last 3 months as reported by the participant and evident at the time of consultation.
- BMI between 19 and 35.
- Provide signed and dated written informed consent.
- Be willing and able to comply with the requirements of the study including taking study medication as directed.
Exclusion Criteria20
- Less than two acne lesions /month.
- Acne of Grade 2 or more on the Modified Leeds Acne Assessment Scale.
- Participants with 10 or more macro comedones.
- Concomitant drug therapy with Vitamin A or its derivatives, tetracyclines, keratolytic or exfoliative antiacne treatments, carbamazepine, spironolactone, azelaic acid, St. Johns Wort or preparations containing St. Johns Wort.
- Participants who have received any antibiotic treatment within the 3 months preceding the start of the study.
- Participants who have used topical retinoids in the month preceding the start of the study (participants using cosmetics that include low dose topical retinoids will not be excluded).
- Females receiving estrogen and/or progesterone treatment, unless on a stable dose for at least 6 months preceding the start of the study and still with persistent acne. If females are using Mirena it must have been in place for at least 6 months preceding the start of the study.
- Participants receiving glucocorticoid treatment within one month preceding the start of the study (except for inhaled corticosteroids for asthma where the dose should be stable throughout the study and not exceed 1 mg/day).
- Participants who have received treatment with isotretinoin within 6 months of the commencement of the study.
- Participants with a known or reported history of Hypervitaminosis A, depression, psychoses, cardiovascular disease, renal disease, lipid disorders, epilepsy, glaucoma, cataract, hepatic disease, diabetes, pancreatitis, blood disorders including anaemia, recurrent migraine headaches, dry eye syndrome or any other condition in the opinion of the investigator that would compromise the safety of the participant or confound the study endpoints. Any participant with a serious or unstable concurrent disease will be excluded from the study.
- Participants who are found to have elevated triglyceride levels or abnormal liver function assessed as clinically significant by the Investigator at the screening blood test.
- Participants with a history of alcohol abuse or drug addiction.
- Participants who are known to be Hepatitis A, B or C or HIV positive at the time of screening.
- Participants who have participated in another drug study in the 60 days preceding the start of the study.
- Participants who are sensitive to isotretinoin and other vitamin A derivatives or are severely allergic to other substances.
- Female participants who are pregnant or who are planning to become pregnant during the course of the study. Female participants must agree to adhere to the study requirement in relation to contraception.
- Females who are breastfeeding.
- Participants who do not agree to NOT donate blood for two months after the completion of the study.
- Participants, who do not, according to the Investigator, understand the information and procedures of the study, in particular the study restrictions and risks involved.
- Participants who are unable to conform to the requirements of the protocol.
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000062820