Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: ORAL ISOTRETNOIN: INDUCTION THERAPY -Cap ISOTRETNOIN @1mg/kg x 6 MONTHS or till remission
MAINTAINENCE THERAPY - TOPICAL ADAPALENE 0.1% GEL x 1 YR
Control Intervention1: ORAL DOXYCYCL
Sponsors
Government Medical College Aurangabad
Eligibility
Inclusion criteria
Inclusion criteria: 1)Subjects with severe acne vulgaris (IGA at least 4), 2)weight between 20-110kg 3) Male or Female subject 4) Age 10-50 yrs inclusive 5) Which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne)
Exclusion criteria
Exclusion criteria: 1)Mild or moderate acne 2) age 50 years 3)deranged liver function tests or any other blood test eg. lipid profile 4)female who are pregnant, nursing or planning pregnancy during the study 5)Acne fulminant, acne conglomerate, secondary acne (drug induced etc), pyoderma faciale, sinus tracts, with known metabolic or structural bone disease 6) subjects with hepatic and renal insufficiency confirmed by blood tests 7) hypervitaminosis A and/or bowel disease 8) Subject with a wash-out period from baseline for systemic treatment of less than: corticosteroids, antibiotics (4 weeks), progesterone for contraception (3 months), spironolactone (3 months),other acne treatments (6 months), cyproterone acetate (6 months). 9) Subject with a wash-out period (from baseline for topical treatment on the face) of less than two weeks (corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments), one week (cosmetic procedures), three months (photodynamic therapy and laser therapy for acne) 10) Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of oral isotretnoin as compared to oral antibiotics (cap doxycycline) with topical adapalene and topical clindamycin gel combination in severe acne vulgaris.Timepoint: Efficacy endpoints were the percent change from baseline in facial nodules, papules/pustules and total lesion counts (sum of comedones, papules/pustules, and nodules), and IGA success rate (defined as improvement upto 1 grade from baseline), at each post-baseline visit. Safety endpoints included incidence of adverse events (AEs) observed by the investigator or reported by the subject. Standard laboratory tests were performed at screening and weeks 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the safety and to find out the adverse effects of oral isotretnoin in patients of severe acne vulgaris. To measure the long term outcomes (benefits and harms) of using oral isotretnoin in patients of severe acne vulgaris. To study safety and efficacy of oral isotretnoin in severe acne vulgaris subgroups such as different areas involvement (face or trunk, or both), different age groups and gender. To study the relationship between the skin type and outcomes of intervention.Timepoint: Efficacy endpoints were the percent change from baseline in facial nodules, papules/pustules and total lesion counts (sum of comedones, papules/pustules, and nodules), and IGA success rate (defined as improvement upto 1 grade from baseline), at each post-baseline visit. Safety endpoints included incidence of adverse events (AEs) observed by the investigator or reported by the subject. Standard laboratory tests were performed at screening and weeks 24. | — |
Countries
India
Contacts
Public ContactDr Kruti Jain
Government Medical College, Aurangabad
Outcome results
None listed