A Study to Assess the Efficacy, Safety and Tolerability of DFD-04

NCT02828241 | Completed Phase 2 Results

• 1 other identifier: DFD04-CD-002
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (3)

• Change in Inflammatory Lesion Counts

  Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.

  At the end of study (12 weeks)

• Number of Subjects With Investigator's Global Assessment (IGA) Success

  Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.

  At the end of study (12 weeks)

• Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale

  Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.

  At end of study (12 weeks)

Study Arms (2)

DFD-04 Ointment

EXPERIMENTAL

DFD-04 (Itraconazole) Ointment

Drug: DFD-04 Ointment

Placebo Ointment

PLACEBO COMPARATOR

Placebo Ointment

Other: Placebo Ointment

Interventions

DFD-04 Ointment DRUG

DFD-04 Ointment

Placebo Ointment OTHER

Also known as: Placebo

Placebo Ointment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
• Subjects must be willing to provide authorization to use protected health information.
• Subjects, any gender or race, must be in good general health as determined by the Investigator
• Subjects must have a clinical diagnosis of papulopustular rosacea, Investigator's Global Assessment (IGA) grade 2 - 3.
• Subjects must have 6 - 30 inflammatory lesions (papules and pustules) of rosacea over the face.
• Subjects must have a Clinician's Erythema Assessment (CEA) score of 2 - 3.
• Subjects must have no more than 2 nodules.
• Subjects must agree to only use the study products and to not use any other treatment for rosacea (prescription or over the counter) or any other skin care or cosmetics product (make-up etc.) on the facial skin of the treatment area during the course of the study.
• Subjects must be free of any systemic or dermatologic disorder, which in the opinion of the Investigator, will interfere with the study results.
• Females have a negative urine pregnancy test at the Screening and Baseline Visit.
• Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 percent per year when used consistently and correctly.
• Subject must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
• Subject is physically able to apply study product to all affected areas.

You may not qualify if:

• Females who are pregnant or nursing or planning to become pregnant during the study.
• Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit.
• Subjects who have been treated with systemic retinoids within 6 months prior to the Baseline visit.
• Subjects who have participated in a trial involving any investigational product in the 30 days prior to the Baseline Visit.
• Subjects with any disease or medical condition that would interfere with the study or place the subject at undue risk especially cardiovascular diseases, reduced lung function (including asthma), renal dysfunction or liver dysfunction.
• Subjects who have been treated within 30 days prior to baseline visit with methadone,disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, terfenadine, astemizole, mizolastine, eletriptan, as well as lovastatin, simvastatin and atorvastatin and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin and solifenacin.
• Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.
• Subjects positive for human immunodeficiency virus (HIV), hepatitis B and hepatitis C-test at screening.
• Subjects who are unable to comply with study requirements.
• Subjects with other skin diseases that may confound the evaluation of rosacea.
• History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
• Subject who in the opinion of the investigator or physician performing the initial examination the subject should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent
• Subject with close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial sites or subject who are an employee of sponsor.
• Subject institutionalized because of legal or regulatory order.
• History of drug or alcohol abuse in the last year.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (8)

Site 201

Berlin, 10117, Germany

Location

Site 208

Berlin, 10783, Germany

Location

Site 202

Bochum, 44803, Germany

Location

Site 205

Hamburg, 22391, Germany

Location

Site 203

Mahlow, 15831, Germany

Location

Site 204

Münster, 48179, Germany

Location

Site 207

Potsdam, 14467, Germany

Location

Site 206

Wiesbaden, 65199, Germany

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Phase 2 pilot study so sample size was small.

Results Point of Contact

• Title: Katherine D'Angelo
• Organization: Dr. Reddy's Laboratories

kdangelo@drreddys.com

609-282-1400

Study Officials

• Srinivas R Sidgiddi, MD

  Dr. Reddy's Laboratories Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Locations

DE (8)