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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04886739
Recruitment Status : Completed
First Posted : May 14, 2021
Last Update Posted : August 9, 2022
Sponsor:
Collaborator:
ethica Clinical Research Inc.
Information provided by (Responsible Party):
CAGE Bio Inc.

Tracking Information
First Submitted Date  ICMJE April 30, 2021
First Posted Date  ICMJE May 14, 2021
Last Update Posted Date August 9, 2022
Actual Study Start Date  ICMJE May 7, 2021
Actual Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rosacea
Intervention  ICMJE
  • Drug: CGB-400
    Topical gel
  • Drug: Vehicle Gel
    Topical gel
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2022)
78
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2021)
80
Actual Study Completion Date  ICMJE December 22, 2021
Actual Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04886739
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party CAGE Bio Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CAGE Bio Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE ethica Clinical Research Inc.
Investigators  ICMJE Not Provided
PRS Account CAGE Bio Inc.
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP