Lateral Gluteal DepressionNCT06656923
Analyze Previously Collected Biopsy Samples From Participants Who Completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" Study
An observational study of Lateral Gluteal Depression, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lateral Gluteal Depression
- What is being tested?
- Biopsies
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 30 Aug 2025
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 16 Females that were previously enrolled and biopsied in SPLASH study.
Who may be able to join
- Subjects who completed all biopsies in the previous SPLASH trial "A Single Center, Double- Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell - Protocol Number Sculptra-Hip-Dell-2021-12" .
Who cannot join
- Subjects who had biopsies of poor quality, insufficient tissue, or were otherwise unsuitable for immunofluorescence analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology/West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: PLLA-ADIPOGENESIS-IFA: Immunofluorescence Analysis to Quantify Changes Induced by Poly-L-Lactic Acid in Adipose Tissue
Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline.
Read the detailed description
Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study. It aims to analyze previously collected biopsy samples from participants who completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" study. The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA (poly-L-lactic acid). We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.
- Conditions
- Lateral Gluteal Depression
- Being tested
- Biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsiesDiagnostic test
Analyze previous biopsies to quantify changes induced by Poly-L-Lactic Acid in Adipose Tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cell count per area between PLLA and saline-treated specimens.
Analyzing between PLLA and saline-treated specimens for the following populations:
- adipocyte derived stem cells
- proliferating adipocyte-derived stem cells
- preadipocytes/adipocyte precursors
- proliferating preadipocytes/adipocyte precursors
- mature adipocytes and actively differentiating precursors The following proteins will be quantified and the differences between PLLA and saline-treated specimens at 6 months compared to pre-treatment will also be analyzed:
- β-catenin
- PPARγ
- Adiponectin
- Perilipin-1
Measured: Specimens are from 6 months post-treatment compared to pre-treatment / Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Nov 2024
- Primary completion28 Feb 2025
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Gluteal DepressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656923
- Sponsor's protocol ID
- PLLA-HIP-DELL-STAINS-2024
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLLA-ADIPOGENESIS-IFA: Immunofluorescence Analysis to Quantify Changes Induced by Poly-L-Lactic Acid in Adipose Tissue
- ClinicalTrials.gov ID
- NCT06656923
- Acronym / sponsor ID
- PLLA-HIP-DELL-STAINS-2024
- Conditions
- Lateral Gluteal Depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 24 Oct 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.
Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline.
Detailed description
Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study. It aims to analyze previously collected biopsy samples from participants who completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" study. The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA (poly-L-lactic acid). We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 16 Females that were previously enrolled and biopsied in SPLASH study.
Key inclusion criteria (1 listed)
- Subjects who completed all biopsies in the previous SPLASH trial "A Single Center, Double- Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell - Protocol Number Sculptra-Hip-Dell-2021-12" .
Key exclusion criteria (1 listed)
- Subjects who had biopsies of poor quality, insufficient tissue, or were otherwise unsuitable for immunofluorescence analysis.
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 |
|---|---|---|
| BiopsiesAnalyze previous biopsies to quantify changes induced by Poly-L-Lactic Acid in Adipose Tissue | Diagnostic test | – |
Primary outcome
Change in cell count per area between PLLA and saline-treated specimens.
Time frame: Specimens are from 6 months post-treatment compared to pre-treatment / Baseline
Analyzing between PLLA and saline-treated specimens for the following populations: * adipocyte derived stem cells * proliferating adipocyte-derived stem cells * preadipocytes/adipocyte precursors * proliferating preadipocytes/adipocyte precursors * mature adipocytes and actively differentiating precursors The following proteins will be quantified and the differences between PLLA and saline-treated specimens at 6 months compared to pre-treatment will also be analyzed: * β-catenin * PPARγ * Adiponectin * Perilipin-1
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 18 Apr 2025.
- Individual participant dataSharing planned: No
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?
An observational study of Lateral Gluteal Depression, run by Goldman, Butterwick, Fitzpatrick and Groff 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 1 inclusion and 1 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 18 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in cell count per area between PLLA and saline-treated specimens. (time frame: Specimens are from 6 months post-treatment compared to pre-treatment / Baseline). 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 18 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.