CTRI/2011/05/001735已完成2 期
Comparative Efficacy, Safety and Tolerability of Topical Isotretinoin Solution 0.1% and Topical Adapalene Gel 0.1% in the Treatment of Acne Vulgaris - An open-label, pilot study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subjects of either sex aged 12 years and above who have given written informed consent or assent to participate in the study. Additional written informed consent will be taken from parents or LAR as applicable in case assent is taken from subjects aged less than 18 yrs.
- •Note This DCGI approved trial has no upper age limit subjects aged more than or equal to 12 years are inclusive
- •2. Diagnosis of Facial Acne Vulgaris with a minimum of 15 but not more than 50 facial inflammatory acne lesions papules and or pustules and a minimum of 20 but not more than 100 facial non-inflammatory acne lesions open and or closed comedones
- •3. Subjects must have a rating of at least grade 2 on Investigators Global Assessment for Acne Vulgaris. However, subjects with nodular acne lesions will not be included.
- •4. Female subjects of child bearing potential practicing an approved method of contraception and willing to continue its use for the duration of the study and have a negative Serum Pregnancy Test at the time of screening or female subjects of non-child bearing potential.
- •Approved methods of contraception include Hormonal contraception including oral, systemic injectable or Intra-uterine Contraceptive Devices must have been on a stable dose for 6 months prior to study entry, bilateral tubal ligation or tubectomy, non-hormonal IUCD, double barrier or strict abstinence.
- •Non-child bearing potential is defined as premenstrual pre-menarche, postmenopausal absence of menstrual bleeding for 1 year prior to enrollment,hysterectomy or bilateral oophorectomy
排除标准
- •1.Subjects with history of hypersensitivity to Isotretinoin, Adapalene or any of the excipients of either of the two formulations or Vitamin A or any other similar drug substances.
- •Excipients of isotretinoin solution are propylene glycol dicaprylate/ dicaprate USNF (Captex 200P), butylated hydroxyanisole USNF, benzoic acid USP
- •Excipients of adapalene gel are carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.
- •2.Subjects who have been previously diagnosed with an endocrinological disorder likely to cause acne such as genital/adrenal hyperplasia, adrenal tumors or any other hypo androgenetic state.
- •3.Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, skin cancer, actinic keratosis or psoriasis) which in the opinion of the investigator may affect the action or evaluation of the study medication or place the subject at undue risk.
- •4.Subjects who are using any of the systemic medications likely to cause or abate acne e.g., oral phenytoin or any other anti-epileptic medication, finasteride, spironolactone, flutamide, testosterone, dietary body-building protein preparations, mega-doses of vitamin D [more than 2000 IU per day], Vitamin A [more than 5000 IU per day] or vitamin B12 [more than 1 mg/day], haloperidol, halogens [e.g., iodide, bromide], lithium or phenobarbital. However, subjects who are using or plan to use multivitamins, iron supplements or folate are acceptable.
- •5.Subjects having any nodulo-cystic acne lesions.
- •6.Use of topical corticosteroids or antibiotics or retinoids within the past 2 weeks on the face or systemic corticosteroids or antibiotics within the past 4 weeks or during the study period. However, use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable.
- •7.Use of facial preparations like abradants, peels, masks, washes, soaps or moisturizers containing glycolic acid, salicylic acid, Alpha- or beta-hydroxy acids or other acids, benzoyl peroxide (BPO) or sulfacetamide sodium within the past 2 weeks or during the study period.
- •8.Subjects who have undergone a facial procedure (e.g., laser peel, microdermabrasion or blue light treatment, etc) within the past 4 weeks or if it is planned to be performed during the conduct of the study.
- •9.Use of systemic retinoids (e.g., oral isotretinoin) within 6 months prior to subject enrollment or during the study period.
- •10.Subjects with excessive facial hair that may interfere with study evaluations.
- •11.Subjects involved in tasks with long exposure to sunlight or use of any known photosensitizing agents like tanning booths, sun lamps, etc during the study period.
- •12.Subjects with a clinically significant disease(s) or disorder(s) other than facial acne vulgaris that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject?s ability to participate in the study.
- •13.Subjects with clinically significant abnormal laboratory value which may affect the participation of the subject in the study.
- •14.Subjects with evidence of substance abuse as per DSM-IV criteria.
- •15.Subjects unwilling or unable to comply with the study procedures.
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