A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Skin Roughness, Wrinkle, Fine Lines, Skin Thickness

In brief

Key facts

Study ID: NCT04540900
Run by: Krystal Biotech, Inc.
People needed: 85
Starts: 2020-10-07
Expected to finish: 2029-05-31
Last updated by the study team: 2025-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female in good general health, as determined by the investigator, aged ≥18 and ≤75 at the time of consent (only females for Cohort 4)
Regions of suitable skin to be selected as Target Area(s), as determined by a physical examination conducted by the investigator during the initial visit:
Cohort 1 - region of healthy buttock skin
Cohort 1a - bilaterally symmetric regions of healthy buttock skin at least 6 cm apart
Cohort 2 - bilaterally symmetric regions of moderate to severe fine lines and skin roughness (score of 2 or 3), as determined by investigator using the 5-point FLS and SRS on the cheeks above and below the zygomatic arch
Cohort 2 Extension- A subject who received a high dose regimen of KB301 to Target Areas below the zygomatic arch
Treatment group- Unilateral region of the cheek below the zygomatic arch, which was randomized to received placebo under Cohort 2, that per investigator assessment and consultation with the sponsor at Visit 1, is determined to be uneven as compared to the Target Area which received KB301
Observational group - Bilateral region of the cheeks below the zygomatic arch which were randomized to receive high dose 301 under Cohort 2 that show durability of KB301 to at least one of the two Target Areas
Cohort 3- Lateral canthal lines of mild to moderate severity at rest, per the Investigator's clinical assessment
Cohort 4- Dynamic décolleté wrinkles and /or pigmentation
A Fitzpatrick skin phototype score of I-IV
A negative pregnancy test at the Study Day 0 Visit for subjects of child-bearing potential and
Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by this protocol.

You may not qualify if…

Any transient or chronic skin condition, disorder, or infection within 20 cm of the Target Areas at Day 0 that, in the opinion of the investigator, may confound study results
History of laser treatment or chemical peels to the Target Areas within six (6) months of the Study Day 0 Visit
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
Administration of a cosmetic and/or clinical research investigational agent, at the location of the Target Areas within 6 months of the Study Day 0 Visit, that, in the opinion of the investigator, may confound study results
Scars, tattoos or tanned skin (defined as skin that is tanned from sun exposure or an applied skin color such as a spray tan) within the Target Area
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
Women who are pregnant or nursing
Subject who is unwilling to comply with contraception requirements per-protocol
Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the investigator.
Previously treated with KB301 under Cohorts 2, 2-extension, 3a, or 3b (Cohort 3c only)

Where it is running

Aesthetx — Campbell, California, United States
Steve Yoelin, MD Medical Associates, Inc. — Newport Beach, California, United States
Mission Dermatology — Rancho Santa Margarita, California, United States
Skin and Cancer Associates, LLP. D/B/A Center for Clinical and Cosmetic Research — Aventura, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.