CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea

• ClinicalTrials.gov Identifier: NCT04886739
• Recruitment Status: Completed
• First Posted: May 14, 2021
• Last Update Posted: August 9, 2022
• Sponsor: CAGE Bio Inc.
• Collaborator: ethica Clinical Research Inc.
• Information provided by (Responsible Party): CAGE Bio Inc.

Tracking Information

• First Submitted Date: April 30, 2021
• First Posted Date: May 14, 2021
• Last Update Posted Date: August 9, 2022
• Actual Study Start Date: May 7, 2021
• Actual Primary Completion Date: December 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2021)

• Inflammatory Lesion Count [ Time Frame: Week 12 ]
  Numerical count of inflammatory lesions (pustules and papules)
• Investigator Global Assessment (IGA) [ Time Frame: Week 12 ]
  • 0 - Clear; No inflammatory lesions present; at most mild erythema
  • 1 - Almost clear; Very mild erythema present. Very few small papules/pustules
  • 2 - Mild; Mild erythema. Several small papules/pustules
  • 3 - Moderate; Moderate erythema. Several small or large papules/pustules
  • 4 - Severe; Severe erythema. Numerous small and/or large papules/pustules

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 10, 2021)

• Inflammatory Lesion Count [ Time Frame: Weeks 2, 4, and 8 ]
  Numerical count of inflammatory lesions (pustules and papules)
• Investigator Global Assessment (IGA) [ Time Frame: Weeks 2, 4, and 8 ]
  • 0 - Clear; No inflammatory lesions present; at most mild erythema
  • 1 - Almost clear; Very mild erythema present. Very few small papules/pustules
  • 2 - Mild; Mild erythema. Several small papules/pustules
  • 3 - Moderate; Moderate erythema. Several small or large papules/pustules
  • 4 - Severe; Severe erythema. Numerous small and/or large papules/pustules
• Rosacea Quality of Life (RosaQoL) Questionnaire [ Time Frame: Week 12 ]
  Patient Reported Outcome

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea
• Official Title: Safety and Effectiveness of CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea: A Randomized, Double-Blind, Vehicle-Controlled Proof of Concept Study

Brief Summary

This is a multicenter, randomized, double-blind, vehicle-controlled, parallel design study evaluating the efficacy and safety of CGB-400 Topical Gel for the treatment of inflammatory lesions of rosacea. The study consists of a 12-week double-blind treatment period with clinic visits at Baseline (Day 0), and Weeks 2, 4, 8, and 12.

Approximately 80 subjects will be enrolled and randomized at a 1:1 ratio to treatment with either CGB-400 Topical Gel (40%) BID or Vehicle Gel BID.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rosacea

Intervention

• Drug: CGB-400
  Topical gel
• Drug: Vehicle Gel
  Topical gel

Study Arms

• Experimental: CGB-400 Topical Gel
  Topical administration twice daily for 12 weeks
  Intervention: Drug: CGB-400
• Placebo Comparator: Vehicle Gel
  Topical administration twice daily for 12 weeks
  Intervention: Drug: Vehicle Gel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 7, 2022): 78
• Original Estimated Enrollment (submitted: May 10, 2021): 80
• Actual Study Completion Date: December 22, 2021
• Actual Primary Completion Date: December 22, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline and practice a reliable method of contraception throughout the study.
• Clinical diagnosis of papulopustular facial rosacea.
• Investigator Global Assessment (IGA) score of 3 or 4 (i.e., moderate or severe).
• Facial inflammatory lesion count (i.e., papules and pustules) of ≥15 and ≤50 (excluding lesions involving the eyes and scalp) with ≤2 nodules.
• Willing to forego any other topical or non-topical treatment, cosmetic, OTC, or prescription on the study areas during treatment (other than sun protection or the study specified face wash and moisturizer).
• Willing to use the provided skincare regimen (e.g., face wash, moisturizer) during the study.
• In general good health as determined by medical history and physical examination at the time of screening (Investigator discretion).
• Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures being performed.

Exclusion Criteria:

• Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control (as specified in Section 5.1).
• Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (i.e., essential oils, fragrance, choline, phosphatidylcholine, propylene glycol, limonene, cellulose).
• Any transient flushing syndrome.
• Particular forms of rosacea (ocular rosacea, rosacea conglobata, rosacea fulminans, isolated rhinophyma, granulomatous rosacea, phymatous rosacea, plaque-type rosacea lesions isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
• Papulopustular rosacea that had required systemic treatment within the past 12 months.
• Facial skin conditions that can interfere with reliable rosacea assessments (e.g., keloids, hypertrophic scarring, dense telangiectasia, plaque-like facial edema, recent facial surgery, etc.).
• Facial dermatoses that may be confounded with papulopustular rosacea (e.g., perioral dermatitis, facial keratosis pilaris, seborrheic dermatitis, acne fulminans, etc.).
• History or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.).
• Basal cell carcinoma within 6 months of Visit 1.
• Uncontrolled systemic disease.
• Foreseen unprotected and intense/excessive UV exposure during the course of the study.
• Use of prohibited concomitant medications/procedures, as specified below in Table 1, during the study or within the defined washout periods.
• Scheduled or planned surgical procedures during the course of the study.
• Unable or unwilling to comply with any of the study requirements.
• Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with study participation or may interfere with interpretation of study results or subject compliance and, in the opinion of the PI, makes the subject inappropriate for study entry.
• Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
• Exposure to any other investigational drug/device within 30 days prior to study entry

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04886739
• Other Study ID Numbers: CGB-400-002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CAGE Bio Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: CAGE Bio Inc.
• Original Study Sponsor: Same as current
• Collaborators: ethica Clinical Research Inc.
• Investigators: Not Provided
• PRS Account: CAGE Bio Inc.
• Verification Date: August 2022