Wrinkles in DecolletagePhase 1/2Pearl-2NCT06724900
A Study Assessing KB304 for the Treatment of Wrinkles in Women
A Phase 1/2 study testing KB304 and 0.9% Normal Saline (NS) in people with Wrinkles in Decolletage and Pigmentation, run by Krystal Biotech, Inc. at 1 site in United States.
Trial summary
The aim of this study is to investigate the safety and efficacy of KB304, an investigational gene therapy to correct moderate to severe wrinkles in the décolleté region (V-shaped chest area). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles in Decolletage, Pigmentation, Décolleté Wrinkles
- What is being tested?
- KB304 and 0.9% Normal Saline (NS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to Aug 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female in good general health, as determined by the Investigator, aged ≥18 and ≤75 at the time of consent.
- Presence of moderate to severe dynamic wrinkles in the décolleté Target Area, as determined by the Investigator on the JDWS.
- A Fitzpatrick skin phototype score of I-IV.
- A negative urine pregnancy test at Screening and Day 1 (Visit 2) for subjects of child-bearing potential.
- Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by the protocol.
Who cannot join
- Any transient or chronic skin condition, disorder, or infection within 20 cm of the Target Area at Day 1 (Visit 2) that, in the opinion of the Investigator, may interfere with the interpretation of study results.
- Scars, tattoos or tanned skin (defined as skin that is tanned from sun exposure, tanning beds, or an applied skin color such as a spray tan) within the Target Area at Day 1 (Visit 2).
- History of laser treatment, microneedling, chemical peels within 3 months of Day 1 (Visit 2), or botulinum toxin within 6 months of Day 1 (Visit 2) to the Target Area.
- History of surgical procedures to Target Area, including removal of benign or malignant skin cancers that, in the opinion of the Investigator, may interfere with the interpretation of study results.
- Administration of a cosmetic and/or investigational agent, in the Target Area within 6 months of Day 1 (Visit 2), that, in the opinion of the Investigator, may interfere with the interpretation of study results.
- Any condition (including a history or current evidence of substance abuse or dependence, ongoing systemic infection, infection local to the Target Area, immunosuppression, or recent history of or active malignancy in the Target Area) that, in the Investigator's opinion, would impact the subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of the Investigational Product.
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- Subject who is 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Steve Yoelin Medical Associates
Newport Beach, California, 92663
About this study
Official title: A Phase 1/2 Study of KB304, a Replication-Defective, Non-Integrating Vector Expressing Human Type III Collagen (COL3) and Tropoelastin for the Treatment of Wrinkles
The aim of this study is to investigate the safety and efficacy of KB304, an investigational gene therapy to correct moderate to severe wrinkles in the décolleté region (V-shaped chest area). KB304 is an investigational gene therapy that delivers functional, full-length human collagen (COL3) and elastin (tropoelastin) to the skin through small injections using the Sponsor's genetically engineered Herpes Simplex Virus (HSV-1) vector. The study is a randomized double-blind study and participants will receive either KB304 (active group) or placebo (inactive group).
- Conditions
- Wrinkles in Decolletage, Pigmentation, Décolleté Wrinkles
- Being tested
- KB304, 0.9% Normal Saline (NS)
- Keywords
- Krystal Biotech, wrinkles in decolletage, pigmentation in decolletage, décolleté wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB304Biological
Genetically modified herpes simplex type 1 virus
0.9% Normal Saline (NS)Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| KB304 | Experimental | Not described Receives: Biological: KB304 |
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9% Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of KB304 versus placebo administered by intradermal injection
Treatment related adverse events as assessed by CTCAE
Measured: Up to 4 months
Secondary outcomes (3)
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Change from baseline as compared to placebo in the Investigator's live assessment (using a 6-Point Global Aesthetic Improvement Scale (GAIS)) and the participants' self-assessment where +2 is much improved and -2 is not applicable.
Measured: Up to 4 months
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Change from baseline as compared to placebo in the Investigator's live assessment (using a 5-Point Jeune Décolleté Wrinkle (JDWS) Photographic Scale) where 0 is none and 4 is extremely severe.
Measured: Up to 4 months
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Change from baseline as compared to placebo in subject satisfaction using a 6-Point Scale where +2 is very satisfied and -2 is not applicable.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start20 Nov 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles in DecolletageStudies of the same condition, open and under way.
- More trials run by Krystal Biotech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krystal Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724900
- Sponsor's protocol ID
- KB304-01
- Acronym
- Pearl-2
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of KB304, a Replication-Defective, Non-Integrating Vector Expressing Human Type III Collagen (COL3) and Tropoelastin for the Treatment of Wrinkles
- ClinicalTrials.gov ID
- NCT06724900
- Acronym / sponsor ID
- Pearl-2 / KB304-01
- Conditions
- Wrinkles in Decolletage, Pigmentation, Décolleté Wrinkles
- Keywords
- Krystal Biotech, wrinkles in decolletage, pigmentation in decolletage, décolleté wrinkles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Krystal Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the safety and efficacy of KB304, an investigational gene therapy to correct moderate to severe wrinkles in the décolleté region (V-shaped chest area). KB304 is an investigational gene therapy that delivers functional, full-length human collagen (COL3) and elastin (tropoelastin) to the skin through small injections using the Sponsor's genetically engineered Herpes Simplex Virus (HSV-1) vector. The study is a randomized double-blind study and participants will receive either KB304 (active group) or placebo (inactive group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KB304 | Experimental | Biological: KB304 |
| Placebo | Placebo comparator | Drug: 0.9% Normal Saline (NS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female in good general health, as determined by the Investigator, aged ≥18 and ≤75 at the time of consent.
- Presence of moderate to severe dynamic wrinkles in the décolleté Target Area, as determined by the Investigator on the JDWS.
- A Fitzpatrick skin phototype score of I-IV.
- A negative urine pregnancy test at Screening and Day 1 (Visit 2) for subjects of child-bearing potential.
- Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by the protocol.
Key exclusion criteria (9 listed)
- Any transient or chronic skin condition, disorder, or infection within 20 cm of the Target Area at Day 1 (Visit 2) that, in the opinion of the Investigator, may interfere with the interpretation of study results.
- Scars, tattoos or tanned skin (defined as skin that is tanned from sun exposure, tanning beds, or an applied skin color such as a spray tan) within the Target Area at Day 1 (Visit 2).
- History of laser treatment, microneedling, chemical peels within 3 months of Day 1 (Visit 2), or botulinum toxin within 6 months of Day 1 (Visit 2) to the Target Area.
- History of surgical procedures to Target Area, including removal of benign or malignant skin cancers that, in the opinion of the Investigator, may interfere with the interpretation of study results.
- Administration of a cosmetic and/or investigational agent, in the Target Area within 6 months of Day 1 (Visit 2), that, in the opinion of the Investigator, may interfere with the interpretation of study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB304Genetically modified herpes simplex type 1 virus | Biological | KB304 |
| 0.9% Normal Saline (NS)Placebo | Drug | Placebo |
Primary outcome
Safety and tolerability of KB304 versus placebo administered by intradermal injection
Time frame: Up to 4 months
Treatment related adverse events as assessed by CTCAE
3 secondary outcomes
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Time frame: Up to 4 months
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Time frame: Up to 4 months
To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Time frame: Up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KB304 and 0.9% Normal Saline (NS) in people with Wrinkles in Decolletage and Pigmentation, run by Krystal Biotech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of KB304 versus placebo administered by intradermal injection (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.