A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects with Papulopustular Rosacea with a 4 Week Follow-up Period
- Conditions
- Papulopustular RosaceaMedDRA version: 18.1Level: PTClassification code 10039218Term: RosaceaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002920-23-SE
- Lead Sponsor
- Cutanea Life Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
1. Subjects who provided written informed consent to participate in the study.
2. Healthy, male and non-pregnant female subjects, 18 years of age or older.
3. A diagnosis of papulopustular rosacea with =30 inflammatory facial lesions (papules, pustules) at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
4. Subjects with the presence of telangiectasia at Baseline.
5. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema (IAE) scale at Baseline.
6. Subjects with a grade 4 (severe rosacea) on the 5-point Investigators Global Assessment (IGA) scale at Baseline.
7. Non-nursing, female subjects of child bearing potential, who are using a highly effective form of birth control or females not of childbearing potential due to menopause (must be postmenopausal for at least one year).
• Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Forms of birth control include: Oral (birth control pills), Intravaginal: (e.g. NuvaRing®), Implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD); double-barrier (diaphragm or condom with spermicidal gel or foam); for two months prior to study enrollment (see exclusion criteria #6) or a vasectomized partner or true abstinence (in line with preferred and usual lifestyle of subject) with an acceptable form of birth control should the subject become sexually active. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. All female subjects of child bearing potential must undergo an in-office, highly sensitive urine pregnancy test, with a negative result, prior to being randomized to receive study drug. In addition, women of childbearing potential must agree to have a highly sensitive urine pregnancy test at the end of the study.
8. Subjects who have used the same brand of soap, make-up, hair products, or shaving lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit and agree not to change these product brand/types during the study.
9. Male subjects who are willing to shave, if applicable, at approximately the same time every day.
10. Subjects who are willing and able to return to the study clinic for the designated study visits.
11. Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or excessive exposure to the sun for the duration of the study.
12. Subjects who are willing to comply with the protocol and visit requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Subjects with clinically significant abnormal findings at the Baseline/Day 1 Visit that would require a new intervention or treatment or a change in treatment that would in the opinion of the investigator supersede participation in the clinical trial.
2. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
3. Subjects with nodular rosacea (defined as more than 2 lesions greater than 5 mm).
4. Subjects with underlying diseases or other dermatological conditions, such as; atopic dermatitis, perioral dermatitis, or seborrheic dermatitis, which requires the use of interfering topical or systemic therapy or may interfere with the rosacea diagnosis or its assessment.
5. Subjects using concomitant treatments that may influence study end points within 2 weeks of the Baseline Visit (e.g., facial or chemical peels, dermal fillers, acne surgery, intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray, laser therapy or UV therapy).
6. If using estrogens or progesteronal agents (e.g, Gynogen, Valergen, Depo-Testadiol, Depogen, birth control pills), for less than 2 months prior to the Baseline Visit. (Subjects using estrogens for 2 months or more need not be excluded unless the subject expects to change dose, drug, or discontinue estrogen use during the study. See Inclusion #7)
7. Subjects with known allergies to the active ingredient or any of the excipients. (See Section7.6.2)
8. Subjects who have not undergone the specified washout period(s) for the following topical preparations applied to the face or subjects who require the concomitant use of any of the following topical preparations/treatments applied to the face:
Product Washout Period
(Prior to Baseline/First Dose)
? Abradants, astringents, toners, facials, masks, or moisturizers
containing retinols, AHA (alpha hydroxyl acids),
salicylic acids, 1 week
? Tanning booths/beds 2 weeks
? Antibiotics (other than topical ocular application) 2 weeks
? Antimicrobial soaps 2 weeks
? Corticosteroids 2 weeks
? Other anti-inflammatories 2 weeks
? Other rosacea treatments (e.g., azelaic acid,
metronidazole, ivermectin, sulfacetamide) 2 weeks
? Retinoids 4 weeks
9. Subjects who have not undergone the specified washout period(s) for the following systemic treatments or subjects who require the concomitant use of any of the following systemic treatments:
Product Washout Period
(Prior to Baseline/First Dose)
? Antibiotics 4 weeks
? Corticosteroids 4 weeks
? Retinoids 12 weeks
10. Female subjects who are pregnant, nursing, or planning a pregnancy within the study period.
11. Subjects who have a beard, or excessive facial hair. A moustache will be allowed, if in the investigator’s judgment it does not impair the assessment of rosacea.
12. Subjects using an investigational drug within 30 days of the Baseline Visit or who are currently participating in an investigational study. Use of an investigational drug/device and/or participation in another investigational study is prohibited during this study.
13. Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse with in the past year.
14. Subjects who have a chronic medical condition that may require the use of a prohibited medication to treat new symptoms or exacerbations.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and efficacy of once daily application of omiganan topical gel compared to vehicle topical gel in subjects with papulopustular rosacea;Secondary Objective: Not applicable;Primary end point(s): Efficacy Endpoints<br>Co-primary Endpoints<br>o The absolute change from Baseline to Week 12 in inflammatory lesions.<br>o IGA at Week 12: 2 grade reduction; Clear or almost Clear (IGA 0, or 1)<br>Safety Endpoints:<br>Adverse events (AE) throughout the study; vital signs at Screening, Week 6 and Week 12; Physical Exam and Safety labs at Screening and Week 12. Immunogenicity will be assessed using samples collected at Baseline, and at Weeks 3, 6, 12 and 16.;Timepoint(s) of evaluation of this end point: Week 12 of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The absolute change from baseline to Week 9 in inflammatory lesions (papules and pustules).<br>o The absolute change from baseline to Week 6 in inflammatory lesions (papules and pustules).<br>o IGA at Week 9: 2 point reduction; Clear or Almost Clear (IGA 0, 1).<br>o IGA at Week 6: 2 point reduction; Clear or Almost Clear (IGA 0, 1).;Timepoint(s) of evaluation of this end point: Week 6 and 9 of treatment