An Open Label, Prospective, Non-comparative, Multicentric, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Fixed Dose Combination of Clindamycin Phosphate IP 1.2 percentage w/w plus Benzoyl Peroxide IP 3.75 percentage w/w Topical Gel in the Treatment of Patients with Acne Vulgaris.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 222
- 试验地点
- 11
研究概览
简要总结
This trial is an open label, prospective, non-comparative, multicentric, phase IV clinical study to evaluate the safety, tolerability and efficacy of fixed dose combination of Clindamycin Phosphate IP 1.2% w/w + Benzoyl Peroxide IP 3.75% w/w Topical Gel 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 or 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 and female) aged between 12 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 40 inflammatory lesions (papules and pustules) and 20 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 patient will be enrolled and provided with study medication at enrolment visit. Patients will be provided with patient diary at enrolment visit, which needs to be brought along with in each subsequent visit till the last visit. Follow up visits will be done on week 4/day 28(±4), week 8/day 56(±4) and week 12/day 84(±4) (Final Visit) of treatment to assess safety, tolerability and efficacy.
研究设计
- 研究类型
- Observational
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 and female patients aged between 12 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris at screening or baseline visit.
- •Patients with an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening or baseline visit.
- •Patient has facial acne vulgaris, with at least 20 to a maximum of 40 inflammatory lesions (papules and pustules) and 20 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.
- •Patients 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 greater than or equal to 18 to smaller than or equal to 65 years) or assent form (for patients aged between greater than or equal to 12 to smaller 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
- •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 who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
- •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.
- •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.
- •Patients with clinically significant impaired hepatic function (SGOT and SGPT more than 3X the UNL) and or renal dysfunction (serum creatinine more than or equal to 2.5 mg by dL) at screening or baseline visit.
- •Patient has 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 screening visit.
- •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 or 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.
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.