A Multicentric, Randomized, Prospective, Active-Controlled, Parallel Group, Evaluator Blind, Comparative and Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Clascoterone Cream 1 percentage w/w in Comparison with Adapalene Gel 0.1 percentage w/w in the Treatment of Patients with Acne Vulgaris.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 228
- 试验地点
- 16
- 主要终点
- Proportion of patients in each treatment group achieving success at Week 12 (success defined as IGA score of clear (score zero) or almost clear (score one) and/or at least a two-point reduction in IGA score compared to baseline).
研究概览
简要总结
This trial is a multicentric, randomized, prospective, active-controlled, parallel group, evaluator blind, comparative and phase III clinical study to evaluate the efficacy, safety and tolerability of Clascoterone Cream 1% w/w in comparison with Adapalene Gel 0.1% w/w in the treatment of patients with acne vulgaris.
Patients who are willing and able to participate in the study will sign and date the Informed Consent or Assent Form on the day of screening / baseline visit (Visit 1). During this screening period, patients who are willing to give consent or assent will be evaluated for all the eligibility criteria. Eligible patients (male or female) aged between 18 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris, who have a score of 2 (mild) or 3 (moderate) on the Investigator’s Global Assessment (IGA) at the screening / baseline visit, has facial acne vulgaris, with at least 20 to a maximum of 50 inflammatory lesions (papules and pustules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones) will be considered for the study.
After confirming the inclusion/exclusion criteria the patients will be randomized and provided with study medication at randomization visit. Patients will be provided with a diary at randomization visit, which need to be brought along in each subsequent visit till the last visit. Follow up visits will be done on week 2/day 14(±3), week 4/day 28(±3), week 8/day 56(±3) and week 12/day 84(±3) (Final Visit) of treatment to assess efficacy, safety and tolerability.
Patients will be assigned to either of the two arms i.e., Arm A or Arm B consisting of Clascoterone Cream 1% w/w or Adapalene Gel 0.1% w/w. (Arm A) Patients will be advised to apply a thin layer (approximately 1 gram) to the affected area twice daily (morning and evening) around same time every day for 12 weeks. (Arm B) Patients will be advised to apply a thin film to the affected areas once a day before bedtime. The affected areas should be dry before application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 12 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris.
- •Patient has an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at the screening or baseline visit.
- •Patients with facial acne vulgaris, with at least 20 to a maximum of 50 inflammatory lesions (papules and pustules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
- •Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study.
- •WOCBP must have a negative urine pregnancy test at screening or baseline visit.
- •Patients agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash and make-up.
- •Subjects should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
- •Patient with ability to understand and provide written, signed and dated informed consent form (for patients aged between more than or equal to 18 to less than or equal to 65 years) or assent form (for patients aged between more than or equal to 12 to less than 18 years), which must have been obtained prior to screening.
- •Patients willing to comply with all the protocol requirements throughout the study.
排除标准
- •Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- •Patients with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- •Patients with excessive facial hair (e.g., heavy beards or moustaches), facial tattoos or facial disfigurement that would interfere with diagnosis or assessment of acne vulgaris.
- •Patient has greater than two (2) facial nodules.
- •Patient has nodulocystic acne.
- •Patient has known hypersensitivity or previous allergic reaction to any of the study medication.
- •Patient has used any of the following products: a)Topical acne treatments (retinoids, antibiotics, Benzoyl Peroxide, Azelaic Acid, Resorcinol, salicylates, α-hydroxy/glycolic acid), or other topical facial medication (antifungals, steroids, anti-inflammatories) on the treatment area in the 14 days prior to the baseline visit, including prescription and non-prescription products.
- •b)Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents (thiazides, phenothiazines), Spironolactone, Flutamide, or immunosuppressant drugs in the 30 days prior to the baseline visit.
- •c)Systemic retinoid use (including high dose vitamin A more than 10,000 units per day) in the 180 days prior to the baseline visit.
- •d)Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in the 30 days prior to the baseline visit.
- •After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
- •e)Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
- •Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL) at screening.
- •Patients with uncontrolled hypertension with sitting systolic BP more than or equal to 160 mmHg and/or diastolic BP more than or equal to 100 mmHg at screening.
- •Patient has any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
- •Patients with a history of experiencing significant burning or stinging when applying any facial treatment (e.g., make-up, soap, masks, washes, sunscreens, etc.) to their face.
- •Patients who have used estrogens or oral contraceptives within 4 weeks prior to randomization.
- •Patients with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.
- •Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent or assent.
- •Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
- •Patients with suspected inability or unwillingness to comply with the study procedures.
- •Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
结局指标
主要结局
Proportion of patients in each treatment group achieving success at Week 12 (success defined as IGA score of clear (score zero) or almost clear (score one) and/or at least a two-point reduction in IGA score compared to baseline).
时间窗: Baseline (Visit 1) and Week 12 (Visit 6).
次要结局
- Mean change from baseline to week 12 in inflammatory lesion (papules and pustules) count.(Baseline (Visit 1), Week 2 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and Week 12 (Visit 6).)
- Mean change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.(Baseline (Visit 1), Week 2 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and Week 12 (Visit 6).)
- Percent change from baseline to week 12 in inflammatory lesion (papules and pustules) count.(Baseline (Visit 1), Week 2 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and Week 12 (Visit 6).)
- Percent change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.(Baseline (Visit 1), Week 2 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and Week 12 (Visit 6).)
- Adverse events and Serious adverse events reported during the study.
- Local tolerability (application site reactions) during the study.(Day 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 8 (Visit 5) and Week 12 (Visit 6).)
- Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).(Baseline (Visit 1) and Week 12 (Visit 6).)
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.