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A Study of KB301 in Adults With Shallow to Moderately Deep Facial Wrinkles and Severe Atrophic Acne Scars.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540900
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Krystal Biotech, Inc.

Brief Summary:
A Phase I Study of KB301 in adults with shallow-to-moderately deep facial wrinkles and severe atrophic acne scars.

Condition or disease Intervention/treatment Phase
Acne Scars Wrinkle Atrophic Acne Scar Hypertrophic Scar Biological: KB301 Other: Placebo Phase 1

Detailed Description:
Twenty-two (22) subjects divided into three (3) cohorts are planned for this Phase I study. Subjects enrolled in Cohort I will present a region of healthy buttock skin as a non-facial target area to receive two (2) injectable doses of KB301 (low or high). The objective of this cohort is to evaluate COL3A1 transgene expression (as measured by qRT-PCR of skin biopsies) and determine the optimal dose for the next 2 cohorts. Subjects enrolled in Cohort II will present two (2) bilaterally symmetrical areas of shallow-to-moderately deep facial wrinkles as the target areas; these areas will be randomly assigned to receive either KB301 or a placebo to determine the extent of wrinkle improvement in the KB 301 arm. Subjects enrolled in cohort III will present two (2) bilaterally symmetrical areas of severe atrophic acne scars as the target areas; these areas will be randomly assigned to receive either KB301 or a placebo to determine the extent of acne scar severity improvement in the KB301 arm. Throughout the study participants will complete questionnaires, have images captured of the target areas, undergo physical examinations, and have safety labs monitored.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Study of KB301, a Replication-incompetent, Non-integrating HSV-1 Vector Expressing Human Type III Collagen (COL3), for the Treatment of Superficial Skin Depressions.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Active Comparator: KB301
non-integrating HSV-1 vector expressing human type III collagen injection
Biological: KB301
non-integrating HSV-1 vector expressing human type III collagen injection

Placebo Comparator: Placebo
sterile isotonic saline injection
Other: Placebo
sterile isotonic saline injection




Primary Outcome Measures :
  1. Assessment of the safety profile of KB301 by recording adverse events. [ Time Frame: 12 months ]
    The primary outcome will look at the safety of KB301 through the collection and quantification of adverse events. The Investigator will collect a description of the adverse event, time of onset, time of resolution, assess severity, and causal relationship to KB301.


Secondary Outcome Measures :
  1. Evaluation of COL3A1 transgene expression 2-days post-dose. [ Time Frame: 12 months ]
    The secondary outcome measure in Cohort 1 will compare a KB301 injection site biopsy, to an area of untreated healthy buttock skin biopsy (at least 6 cm away from the sites of KB301 injection), via qRT-PCR analysis.

  2. Investigator assessment of wrinkle improvement over baseline, using a 5-point Wrinkle Assessment Scale (WAS). [ Time Frame: 12 months ]
    The secondary outcome measure in Cohort 2 will look at the mean change in Investigator assessment of wrinkles severity as compared to baseline, using a 5-point wrinkle assessment scale (WAS), which is scored on a scale from 0-4, with 0 indicating no visible wrinkles and 4 indicating very deep wrinkles.

  3. Subject assessment of aesthetic improvement over baseline, using the Subject Satisfaction Scale (SSS). [ Time Frame: 12 months ]
    The secondary outcome measure in Cohorts 2 and 3, will look at the mean change in Subject's Satisfaction with the treatment per target area, as compared to baseline, using the Subject Satisfaction Scale (SSS), which is scored on a scale from 0-4, with 0 indicating not satisfied and 4 indicating excellent.

  4. Investigator assessment of acne scar improvement over baseline, using the Acne Scar Severity Scale (SCAR-S). [ Time Frame: 12 months ]
    The secondary outcome measure in Cohort 3, will look at the mean change of Acne Scar Severity (SCAR-S) as compared to baseline, using a 6-point scale, with 0 indicating clear skin with no visible scars from acne and 5 indicating very severe scars affecting the entire area.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female in good general health, as determined by the Investigator, aged ≥18 and ≤75 at the time of consent.
  2. Regions of suitable skin to be selected as Target Area(s), as determined by a physical examination conducted by the Investigator during a screening visit

    1. Cohort 1 - single region of healthy buttock skin;
    2. Cohort 2 -two bilaterally symmetrical regions of shallow-to-moderately deep facial wrinkles; and
    3. Cohort 3 - two bilaterally symmetrical regions of moderate-to-severe atrophic acne scars.
  3. A Fitzpatrick skin phototype score of I-IV.
  4. A negative pregnancy test at the Study Day 0 Visit for subjects of child-bearing potential.
  5. Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by this protocol.

Exclusion Criteria:

  1. Any transient or chronic skin condition, disorder, or infection within 20 cm of the Target Areas that, in the opinion of the Investigator, may confound study results.
  2. History of laser treatment or chemical peels to the Target Areas within six months of the Study Day 0 Visit.
  3. History of surgical procedures to Target Areas, including removal of benign or malignant skin cancers that, in the opinion of the Investigator, may confound study results.
  4. Administration of a cosmetic and/or clinical research investigational agent, excluding KB301, in close proximity to the Target Areas within 12 months of the Study Day 0 Visit, that, in the opinion of the Investigator, may confound study results.
  5. Any condition (including a history or current evidence of substance abuse or dependence) that, in the Investigator's opinion, would impact subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of the Investigational Product.
  6. An active oral herpes infection at the Screening Visit or Study Day 0 Visit.
  7. Women who are pregnant or nursing.
  8. Subject who is unwilling to comply with contraception requirements per protocol.
  9. A history of anaphylaxis or allergic reactions to any of the constituents of the product and/or local anesthetics.
  10. Clinically significant abnormalities of hematology or chemistry testing at screening visit that the Investigator believes may interfere with the assessment of safety and/or efficacy of the study treatment.
  11. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540900


Contacts
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Contact: Nathan Angeloff 412-586-5830 ext 1078 nangeloff@krystalbio.com

Locations
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United States, Florida
Skin and Cancer Associates, LLP. D/B/A Center for Clinical and Cosmetic Research Recruiting
Aventura, Florida, United States, 33180
Contact: Vanessa Gervais       v.gervais@admcorp.com   
Principal Investigator: Mark S Nestor, MD         
Sponsors and Collaborators
Krystal Biotech, Inc.
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Responsible Party: Krystal Biotech, Inc.
ClinicalTrials.gov Identifier: NCT04540900    
Other Study ID Numbers: PEARL-1
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krystal Biotech, Inc.:
KB301
Wrinkles
Acne Scars
Krystal Biotech
Additional relevant MeSH terms:
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Acne Vulgaris
Atrophy
Cicatrix, Hypertrophic
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Cicatrix
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical