Prospective, randomized comparative study to evaluate safety, tolerability and efficacy of topical minocycline gel 4% plus oral isotretinoin vs oral isotretinoin only in Indian patients with moderate to severe acne vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Acne vulgaris is the most common dermatologic disorder globally,affecting approximately 85 percent of the adolescent population, although itcan persist into adulthood, therefore affecting almost all age groups. Acnevulgaris is the most common dermatologic disorder globally, affectingapproximately 85 percent of the adolescent population, although it can persistinto adulthood, therefore affecting almost all age groups.
As per the guidelines, it is suggested to use combination therapy alongwith oral antibiotics or isotretinoin but monotherapy with antibiotics iscontraindicated. Concomitant use of minocycline and isotretinoin is notrecommended in view of possibility of pseudo tumor cerebri. But as per onestudy, concomitant use of oral doxycycline and isotretinoin was found to besafe and effective when used on alternate days.
Though, combination of oralminocycline and isotretinoin is not recommended, topical minocycline was foundto 765 times less absorbed systemically and hence all systemic adverse eventsassociated with oral minocycline were nullified by topical minocycline. Hence,the objective of the study is to investigate the safety and efficacy ofcombination of topical minocycline gel 4% and oral isotretinoin and compareagainst isotretinoin only in the management of acne vulgaris in Indianpopulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Time Frame is up to 84 days
Evaluation of Treatment Emergent Adverse Events Evaluation of cutaneous tolerability of drugs like signs of cutaneous atrophy, epidermal
时间窗: Time Frame is up to 84 days
thickening/lichenification and abnormal pigmentation changes.
时间窗: Time Frame is up to 84 days
次要结局
- Investigator Global Assessment treatment.(improvement or decrease.)