NCT07376148

Brief Summary

Evaluate the effectiveness of topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment in objectively reversing facial skin alterations induced by photoaging.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

Keywords

Skin QualityFractional Ablative Resurfacing;Topical Drugs

Outcome Measures

Primary Outcomes (1)

  • Skin quality

    Quantitative enhancement that can be assessed using a validated scale (SASSQ)

    From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following

EXPERIMENTAL

Participants will attend a total of four sessions. During the initial session, participants will complete and sign a consent form, baseline photographs will be captured for documentation purposes, and an initial assessment will be conducted using the SASSQ. At the second session, the fractional CO2 laser will be applied, followed by the application of the topical medication to the facial area. During the third and fourth sessions, scheduled one week and four weeks post-treatment, respectively, the facial dermal effects will be objectively evaluated using the SASSQ scale, and any adverse effects will be assessed and documented through photographs.

Drug: topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment

Interventions

The study involves the application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following the administration of a fractional CO2 laser treatment

Application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects, over 30 years of age, with moderate skin changes associated with elasticity, wrinkles, roughness, pigmentation, erythema, and pore size; with at least 12 points on the SASSQ scale. Fitzpatrick skin type I-III. Participants who agree to take part in the protocol

You may not qualify if:

  • Fitzpatrick skin type IV-VI. Local infections or inflammatory disorders.. Neoplasms suspected of being malignant. Allergy to hyaluronic acid, ascorbic acid, and sodium DNA. Hypersensitivity to fractional CO2 laser. Pregnancy or breastfeeding. Local or systemic adverse reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Oftalmología F.A.P. Conde de Valenciana, I.A.P.

Mexico City, Mexico City, 06800, Mexico

RECRUITING

Related Publications (33)

  • Kieser M, Wassmer G. On the use of the upper confidence limit for the variance from a pilot sample for sample size determination. Biom J. 1996;38(8):941-9. doi: 10.1002/bimj.4710380806

    RESULT
  • Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.

  • Eiben-Nielson C, Kerscher M. Development and validation of a global photonumeric scale for evaluating skin quality of aged female facial skin. J Cosmet Dermatol. 2021 Dec;20(12):4032-4039. doi: 10.1111/jocd.14058. Epub 2021 Mar 24.

  • Fitzpatrick RE. Maximizing benefits and minimizing risk with CO2 laser resurfacing. Dermatol Clin. 2002 Jan;20(1):77-86. doi: 10.1016/s0733-8635(03)00047-0.

  • Iaconisi GN, Lunetti P, Gallo N, Cappello AR, Fiermonte G, Dolce V, Capobianco L. Hyaluronic Acid: A Powerful Biomolecule with Wide-Ranging Applications-A Comprehensive Review. Int J Mol Sci. 2023 Jun 18;24(12):10296. doi: 10.3390/ijms241210296.

  • Palomar-Llatas F, Castellano-Rioja E, Arantón-Areosa L, Fornes-Pujalte B, Palomar-Albert D, Díez-Fornes P, et al. Abordaje de las lesiones cutáneas más frecuentes en el envejecimiento. Enfermería Dermatológica [Internet]. 2020;14(39). doi: 10.5281/zenodo.3779297

    RESULT
  • Holck DE, Ng JD. Facial skin rejuvenation. Curr Opin Ophthalmol. 2003 Oct;14(5):246-52. doi: 10.1097/00055735-200310000-00004.

  • Cafardi JA, Elmets CA. T4 endonuclease V: review and application to dermatology. Expert Opin Biol Ther. 2008 Jun;8(6):829-38. doi: 10.1517/14712598.8.6.829.

  • Yarosh DB, Rosenthal A, Moy R. Six critical questions for DNA repair enzymes in skincare products: a review in dialog. Clin Cosmet Investig Dermatol. 2019 Aug 29;12:617-624. doi: 10.2147/CCID.S220741. eCollection 2019.

  • Ge S, Chung HJ, Weiss RA. Histologic Effects of Fractional Lasers and Energy-Based Devices on Intradermally Injected Hyaluronic Acid Filler for Improving Skin Smoothness. Lasers Surg Med. 2025 Jan;57(1):96-100. doi: 10.1002/lsm.23863. Epub 2024 Nov 29.

  • Zhang J, Xu F, Lin H, Ma Y, Hu Y, Meng Q, Lin P, Zhang Y. Efficacy of fractional CO2 laser therapy combined with hyaluronic acid dressing for treating facial atrophic acne scars: a systematic review and meta-analysis of randomized controlled trials. Lasers Med Sci. 2023 Sep 19;38(1):214. doi: 10.1007/s10103-023-03879-y.

  • Weinstein-Oppenheimer CR, Brown DI, Coloma R, Morales P, Reyna-Jeldes M, Díaz MJ, Sánchez E, Acevedo CA. Design of a hybrid biomaterial for tissue engineering: Biopolymer-scaffold integrated with an autologous hydrogel carrying mesenchymal stem-cells. Mater Sci Eng C Mater Biol Appl. 2017 Oct 1;79:821-830. doi: 10.1016/j.msec.2017.05.116

    RESULT
  • Murphy SV, Skardal A, Song L, Sutton K, Haug R, Mack DL, Jackson J, Soker S, Atala A. Solubilized Amnion Membrane Hyaluronic Acid Hydrogel Accelerates Full-Thickness Wound Healing. Stem Cells Transl Med. 2017 Nov;6(11):2020-2032. doi: 10.1002/sctm.17-0053. Epub 2017 Sep 23.

  • Fanian F, Deutsch JJ, Bousquet MT, Boisnic S, Andre P, Catoni I, Beilin G, Lemmel C, Taieb M, Gomel-Toledano M, Issa H, Garcia P. A hyaluronic acid-based micro-filler improves superficial wrinkles and skin quality: a randomized prospective controlled multicenter study. J Dermatolog Treat. 2023 Dec;34(1):2216323. doi: 10.1080/09546634.2023.2216323. Epub 2023 Aug 14.

  • Abatangelo G, Vindigni V, Avruscio G, Pandis L, Brun P. Hyaluronic Acid: Redefining Its Role. Cells. 2020 Jul 21;9(7):1743. doi: 10.3390/cells9071743.

  • Boo YC. Ascorbic Acid (Vitamin C) as a Cosmeceutical to Increase Dermal Collagen for Skin Antiaging Purposes: Emerging Combination Therapies. Antioxidants (Basel). 2022 Aug 26;11(9):1663. doi: 10.3390/antiox11091663.

  • Bhowmick S, Rother S, Zimmermann H, Lee PS, Moeller S, Schnabelrauch M, Koul V, Jordan R, Hintze V, Scharnweber D. Biomimetic electrospun scaffolds from main extracellular matrix components for skin tissue engineering application - The role of chondroitin sulfate and sulfated hyaluronan. Mater Sci Eng C Mater Biol Appl. 2017 Oct 1;79:15-22. doi: 10.1016/j.msec.2017.05.005. Epub 2017 May 4.

  • Njus D, Kelley PM, Tu YJ, Schlegel HB. Ascorbic acid: The chemistry underlying its antioxidant properties. Free Radic Biol Med. 2020 Nov 1;159:37-43. doi: 10.1016/j.freeradbiomed.2020.07.013. Epub 2020 Jul 30.

  • Waibel JS, Mi QS, Ozog D, Qu L, Zhou L, Rudnick A, Al-Niaimi F, Woodward J, Campos V, Mordon S. Laser-assisted delivery of vitamin C, vitamin E, and ferulic acid formula serum decreases fractional laser postoperative recovery by increased beta fibroblast growth factor expression. Lasers Surg Med. 2016 Mar;48(3):238-44. doi: 10.1002/lsm.22448. Epub 2015 Nov 27.

  • Hsiao CY, Huang CH, Hu S, Ko YS, Sung HC, Chen CC, Huang SY. Fractional carbon dioxide laser treatment to enhance skin permeation of ascorbic acid 2-glucoside with minimal skin disruption. Dermatol Surg. 2012 Aug;38(8):1284-93. doi: 10.1111/j.1524-4725.2012.02454.x. Epub 2012 Jun 5.

  • Farris PK. Topical vitamin C: a useful agent for treating photoaging and other dermatologic conditions. Dermatol Surg. 2005 Jul;31(7 Pt 2):814-7; discussion 818. doi: 10.1111/j.1524-4725.2005.31725.

  • Ibrahim O, Wenande E, Hogan S, Arndt KA, Haedersdal M, Dover JS. Challenges to laser-assisted drug delivery: Applying theory to clinical practice. Lasers Surg Med. 2018 Jan;50(1):20-27. doi: 10.1002/lsm.22769. Epub 2017 Nov 20.

  • Muskat A, Kost Y, Balazic E, Cohen JL, Kobets K. Laser-Assisted Drug Delivery in the Treatment of Scars, Rhytids, and Melasma: A Comprehensive Review of the Literature. Aesthet Surg J. 2023 Feb 21;43(3):NP181-NP198. doi: 10.1093/asj/sjac286.

  • Waibel JS, Rudnick A. Laser-assisted delivery to treat facial scars. Facial Plast Surg Clin North Am. 2017;25(1):105-17. doi: 10.1016/j.fsc.2016.08.010

    RESULT
  • Seo HM, Choi JY, Min J, Kim WS. Carbon dioxide laser combined with botulinum toxin A for patients with periorbital syringomas. J Cosmet Laser Ther. 2016 Jun;18(3):149-53. doi: 10.3109/14764172.2015.1052517. Epub 2016 Mar 31.

  • Mohamed HA, Mohammed GF, Gomaa AH, Eyada MM. Carbon dioxide laser plus topical 5-fluorouracil: a new combination therapeutic modality for acral vitiligo. J Cosmet Laser Ther. 2015;17(4):216-23. doi: 10.3109/14764172.2014.1003241. Epub 2015 Jan 30.

  • Franz TJ. Kinetics of cutaneous drug penetration. Int J Dermatol. 1983 Nov;22(9):499-505. doi: 10.1111/j.1365-4362.1983.tb02187.x. No abstract available.

  • Scott JA, Banga AK. Cosmetic devices based on active transdermal technologies. Ther Deliv. 2015;6(9):1089-99. doi: 10.4155/tde.15.64. Epub 2015 Sep 21.

  • Haedersdal M, Sakamoto FH, Farinelli WA, Doukas AG, Tam J, Anderson RR. Fractional CO(2) laser-assisted drug delivery. Lasers Surg Med. 2010 Feb;42(2):113-22. doi: 10.1002/lsm.20860.

  • Alegre-Sánchez A, Jiménez-Gómez N, Boixeda P. Vehiculización de fármacos asistida por láser. Actas Dermo-sifiliográficas. 2018;109:858-867. doi: 10.1016/j.ad.2018.07.008

    RESULT
  • Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.

  • Zaleski-Larsen LA, Fabi SG. Laser-Assisted Drug Delivery. Dermatol Surg. 2016 Aug;42(8):919-31. doi: 10.1097/DSS.0000000000000556.

  • de Szalay S, Wertz PW. Protective Barriers Provided by the Epidermis. Int J Mol Sci. 2023 Feb 5;24(4):3145. doi: 10.3390/ijms24043145.

MeSH Terms

Interventions

Hyaluronic AcidAscorbic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Central Study Contacts

Daniel B Mejia Llanes MD, Medical Doctor

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The study involves the application of ascorbic acid, hyaluronic acid, and sodium DNA in preparation for their use following the administration of a fractional CO2 laser treatment. Participants will attend a total of four sessions. During the initial session, participants will complete and sign a consent form, baseline photographs will be captured for documentation purposes, and an initial assessment will be conducted using the SASSQ. At the second session, the fractional CO2 laser will be applied, followed by the application of the topical medication to the facial area. During the third and fourth sessions, scheduled one week and four weeks post-treatment, respectively, the facial dermal effects will be objectively evaluated using the SASSQ scale, and any adverse effects will be assessed and documented through photographs. To facilitate the analysis and comparison of variables, an analysis of variance will be conducted utilizing the ANOVA test for repeated measures.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

November 7, 2025

Primary Completion

February 28, 2026

Study Completion

April 30, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Abril 2026 - December 2026

Locations