Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention1: Minocycline Hydrochloride topical gel 4% plus Oral isotretinoin: Dosage Form is Gel
Dosage is Once daily for 12 weeks
Dosage Frequency is Once a day
Mode of Administration is Once dai
Sponsors
Glenmark Pharmaceuticals Limited
Infoclin LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient has completed and signed an appropriately administered Informed Consent Form prior to any study related procedures. Patients less than 18 years of age must sign an Assent Form for the study. 2.Patients who have facial acne vulgaris with an IGA score of moderate 3 or severe 4. 3.Willing and able to apply minocycline gel 4% and take oral isotretinoin capsules as directed comply with study instructions and commit to visit the site for all follow up visits for the duration of the study. 4.If sexually active male patient must practice true abstinence or agree to use contraception during the study. Male patients should refrain from making sperm donations at any time during study participation and for at least 30 days following treatment discontinuation. 5. Willing to minimize exposure of the treated skin to ultraviolet light and extremes in weather such as wind or cold throughout the study. 6.Patient is in good general health and is free of any disease state or physical condition that exposes the patient to an unacceptable risk by study participation or impairs the evaluation of the patient or the treatments by participating in the study.
Exclusion criteria
Exclusion criteria: 1.Female who is pregnant lactating or breastfeeding, or is planning a pregnancy during the study. 2.Patients having Acne conglobata, acne fulminans secondary acne or any dermatological condition of the face that would require the use of confounding therapies or facial hair that could either interfere with clinical evaluations. 3.Patients with Sunburn on the face. 4.Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results. 5.Abnormal Screening laboratory values that are considered clinically significant 6.Patient is currently enrolled in another investigational drug clinical trial or device study or is using or has used an investigational drug or investigational device treatment within 30 days of randomization. 7.Patient who in the opinion of the investigator, is unable or unlikely to comply with the requirements of the study protocol. 8.Patients excluded who have a history with Allergy to tetracycline class antibiotics or to any ingredient in the study drug, Pseudomembranous colitis or antibiotic-associated colitis, Hepatitis or liver damage or renal impairment, suspected premalignant or malignant disease 9.Patient not eligible, Within 1 week prior to randomization Medicated facial cleansers, Topical acne treatments, within 4 weeks with Topical retinoids on the face, Topical anti inflammatories Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10 percent of body surface area. In flexural body areas,Systemic antibiotics, Systemic acne treatments Within 12 weeks prior to randomization with Systemic retinoid. 10.Patient has any acute illness within 48 hours, history of sensitivity,depression,Drug addiction or alcohol abuse,previous use of isotretinoin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the safety of combination of topical minocycline gel 4% and oral isotretinoin vs oral isotretinoin in Indian patients with moderate to severe acne vulgaris. Evaluation of Treatment Emergent Adverse Events Evaluation of cutaneous tolerability of drugs like signs of cutaneous atrophy, epidermal thickening/lichenification and abnormal pigmentation changes. Timepoint: Time Frame is up to 84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator Global Assessment treatment. improvement or decrease. Change from baseline in the inflammatory, non-inflammatory and nodulocystic lesion count.Timepoint: 1. IGA at week 4, 8 and 12. 2. Change from baseline in the inflammatory, noninflammatory and nodulocystic lesion count at Weeks 4, 8 and 12. | — |
Countries
India
Contacts
Public ContactMr Swapan Biswas
Infoclin LLP
Outcome results
None listed