Clinical Trials

Numerous clinical trials spanning phase 1 through phase 4 have evaluated L-lactic acid and its polymeric formulations across dermatological aesthetic concerns—including facial lipoatrophy, skin aging, perioral wrinkles, and skin laxity—alongside critical care conditions such as septic shock. Sponsored by a mix of industry entities, clinical specialty groups, and academic centers, the majority of these studies have reached completed status, while others remain actively recruiting or pending initiation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07680426 NOT_YET_RECRUITING
Photodamaged Skin; Skin Cancer Prevention
Bispebjerg Hospital
 2026-09-01
NCT07261527 NOT_YET_RECRUITING
Skin Texture
The University of Texas Health Science Center, Houston
 2025-11-24
NCT07637188 RECRUITING
Skin Laxity
Nordberg Medical Italy srl
 2026-05-13
NCT07544667 RECRUITING
Pelvic Organ Prolapse (POP); Cystocele; Pelvic Floor Disorder
Cassandra Kisby
 2026-08-20
NCT07343141 NOT_YET_RECRUITING
Nasolabial Fold Correction
SciVision Biotech Inc.
 2026-06-01
NCT07342452 NOT_YET_RECRUITING
Skin Aging
Massachusetts General Hospital
 2026-07 PHASE4
NCT07332650 NOT_YET_RECRUITING
Skin Quality; Skin Laxity
Nordberg Medical AB
 2026-10
NCT07523217 RECRUITING
Atrophic Acne Scarring
Zagazig University
 2024-03-15
NCT06948045 NOT_YET_RECRUITING
Skin Laxity; Facial Aging
Doris Hexsel
 2026-02-01
NCT07202117 RECRUITING
Aesthetic
Erevna Innovations Inc.
 2025-11-01 PHASE4
NCT07342400 RECRUITING
Cheek Wrinkles; Menopausal Women
Galderma R&D
 2025-08-12
NCT07217743 NOT_YET_RECRUITING
Laxity; Skin
Goldman, Butterwick, Fitzpatrick and Groff
 2025-10-27 PHASE2
NCT07689344 NOT_YET_RECRUITING
Skin Aging; Wrinkles
Institute of Dermatology, Thailand
 2026-07-01
NCT06993558 RECRUITING
This Study Aims to Evaluate the Safety Profile and Tissue Changes After Biostimulatory Treatments to the Face in Healthy Volunteers
Universitätsklinikum Hamburg-Eppendorf
 2025-07-31
NCT07225348 RECRUITING
Perioral Wrinkles
Skincare Physicians of Chestnut Hill
 2025-11-07 PHASE4
NCT06013332 UNKNOWN
Nasolabial Fold Wrinkles
Taipei Medical University Hospital
 2024-04-15
NCT06337747 COMPLETED
Aging
Erevna Innovations Inc.
 2023-05-19
NCT05269654 UNKNOWN
Skin Laxity
Goldman, Butterwick, Fitzpatrick and Groff
 2022-03-04
NCT05913102 UNKNOWN
Pigmentation; Pigmentation Disorder
Jin Cheol Kim
 2022-09-28
NCT05445661 UNKNOWN
Skin Laxity
Goldman, Butterwick, Fitzpatrick and Groff
 2022-07-20
NCT07775092 COMPLETED
Acne Atrophica; PRP
Tanta University
 2023-02-06
NCT05538728 COMPLETED
Wrinkles in Decolletage
Galderma R&D
 2022-08-31
NCT05620043 COMPLETED
Gene Expression
Galderma R&D
 2022-09-28
NCT05608239 UNKNOWN
Lipoatrophy; Aging
Sadick Research Group
 2022-11
NCT05064761 COMPLETED
Cellulite
Galderma R&D
 2021-11-19
NCT04957446 UNKNOWN
Nasolabial Fold; Facial Wrinkles
Sadick Research Group
 2021-08-09
NCT04830722 UNKNOWN
Cellulite
Goldman, Butterwick, Fitzpatrick and Groff
 2021-04-09
NCT02425943 COMPLETED
Nasolabial Fold Contour Deficiencies; Wrinkles
Galderma R&D
 2015-05-21 PHASE4
NCT03858543 COMPLETED
Striae Distensae
Henry Ford Health System
 2019-07-15 EARLY_PHASE1
NCT03922464 COMPLETED
Buttock Contouring; Buttock Lifting
Erevna Innovations Inc.
 2019-04-08 PHASE4
NCT03487172 COMPLETED
Lax Skin; Knee
Goldman, Butterwick, Fitzpatrick and Groff
 2018-04-10
NCT02310490 COMPLETED
Face; Atrophy
DermAvance
 2015-01
NCT02975739 TERMINATED
Radioisotopes; Head and Neck Neoplasms
UMC Utrecht
 2016-09
NCT03225066 COMPLETED
Flaccidity, Muscle
Galderma Brasil Ltda.
 2017-08-21
NCT02208804 UNKNOWN
Colorectal Neoplasms; Neoplasm Metastasis; Liver Diseases; Digestive System Neoplasms
UMC Utrecht
 2014-11 PHASE2; PHASE3
NCT02613481 COMPLETED
Facial Volume Loss
Yardley Dermatology Associates
 2015-11
NCT02003833 COMPLETED
Skin Aging
Sadick Research Group
 2013-09 PHASE4
NCT01307865 COMPLETED
Problem of Aging
Williams Center Plastic Surgery Specialists
 2011-01 PHASE4
NCT00869687 COMPLETED
Healthy Volunteers
Bausch Health Americas, Inc.
 2009-03
NCT00795327 COMPLETED
Acne Vulgaris
Bausch Health Americas, Inc.
 2008-10
NCT00447551 COMPLETED
Skin Aging
Bausch Health Americas, Inc.
 2007-01 PHASE4
NCT00126308 TERMINATED
HIV-Associated Lipodystrophy; HIV Infections
Kirby Institute
 2005-11 PHASE4
NCT00360932 Completed
Facial Lipoatrophy
Bausch Health Americas Inc.
 2005-10 --
NCT00444353 COMPLETED
Nasolabial Fold Wrinkles
Bausch Health Americas, Inc.
 2004-08 PHASE3
NCT00444210 COMPLETED
Nasolabial Fold Wrinkles
Bausch Health Americas, Inc.
 2004-06 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-02)

Check the L-Lactic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Lactic acid acts as a signaling metabolite and biocompatible matrix scaffold that engages cell-surface hydroxycarboxylic acid receptors and alters extracellular microenvironment pH to stimulate subepidermal fibroblast proliferation and neocollagenesis. This upregulation of extracellular matrix deposition promotes structural tissue regeneration and dermal remodeling, providing a biomechanical basis for reversing facial lipoatrophy and skin aging observed in clinical evaluation.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.