Acne vulgaris
Conditions
Interventions
Product Code: DFD-03 Lotion
Pharmaceutical Form: Cutaneous emulsion
INN or Proposed INN: TAZAROTENE
CAS Number: 118292-40-3
Concentration unit: % percent
Concentration type: equal
Concentration number
Sponsors
Dr. Reddy’s Laboratories, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject understands the study procedures, is willing to comply with the study procedures and required visits and agrees to participate by giving written informed consent. Subjects under the legal age of consent (i.e. 100 ? Diastolic BP 50 ? Pulse 50 – 90 bpm inclusive Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-6
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant or lactating or planning to become pregnant during the study period. 2. Treatment with the following products: a. Topical acne treatments (retinoids, antibiotics, benzoyl peroxide, azelaic acid, resorcinol, salicylates, a-hydroxy/glycolic acid) or other topical facial medication (antifungals, steroids, anti-inflammatory) on the treatment area in the 14 days prior to the Baseline Visit including prescription and non-prescription products. b. Systemic corticosteroids, systemic antibacterials, systemic acne treatments, photosensitizing agents (thiazides, phenothiazines), spironolactone, flutamide, or immunosuppressant drugs in the 30 days prior to the Baseline Visit. c. Systemic retinoid (including high dose vitamin A >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 30 days prior to Baseline Visit. e. Treatment with a medication that would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study. f. Treatment with an investigational product or device in the 30 days prior to the Baseline Visit. 3. Known hypersensitivity to retinoids or tazarotene or any of the other ingredients of these products. 4. Subjects who are photosensitive. 5. Presence of any facial skin disease or condition including sunburn, rosacea, seborrheic dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema at Baseline, squamous cell carcinoma and other skin malignacies, acneform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis or any other facial disease or condition that would interfere with the study or place the subject at unacceptable risk. 6. Excessive facial hair (i.e. heavy beard or moustache), facial tattoos or facial disfigurement that would interfere with study assessments. 7. Subjects with a serious and/or chronic medical condition (other than well controlled hypertension) like chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions (other than controlled diabetes) or any other disease that in the opinion of the investigator would interfere with the study or place the subject at unacceptable risk. 8. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year prior to the Baseline Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to assess the efficacy and safety of DFD-03 Lotion in comparison to Vehicle Lotion in patients with acne vulgaris after 12 weeks of topical treatment.;Secondary Objective: Not applicable;Primary end point(s): 1. Absolute Change from Baseline in inflammatory lesion counts at Week 12 2. Absolute Change from Baseline in non-inflammatory lesion counts at Week 12 3. Proportion of subjects achieving success at Week 12 with success defined as a score of “clear” or “almost clear” (IGA Score of 0 or 1) and a two or more grade (IGA) improvement from Baseline. ;Timepoint(s) of evaluation of this end point: Day 1 (baseline) and day 84 +/- 5 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with a 2 grade reduction in IGA scores from baseline 2. Percent change in inflammatory and non-inflammatory lesion counts from Baseline to Week 12 ;Timepoint(s) of evaluation of this end point: Day 1 (baseline) and day 84 +/- 5 days. | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
bioskin GmbH
Outcome results
None listed