ClinicalTrials.gg
RecruitingNCT07376148FCLADHAAASDFSQUpdated Jan 29, 2026

Fractional CO2 Laser-assisted Delivery of Hyaluronic Acid, Ascorbic Acid and Sodium DNA For Enhancing Facial Skin Quality in Individuals Over the Age of 30

A Phase 4 interventional study of topical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment in Skin Quality Improvement, Photo-aged Skin and Drug Delivery Systems, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Recruiting at 1 site in Mexico. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Nov 2025; still recruiting 1 year later.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
30 Years and older
Sex
All
01

Study 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.

Read the detailed description

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. The IBM SPSS Statistics software, version 29.0, will be employed for this purpose. A p-value of less than 0.05 will be regarded as statistically significant.

02

Conditions studied

  • Skin Quality Improvement
  • Photo-aged Skin
  • Drug Delivery Systems

Keywords

  • Skin Quality
  • Fractional Ablative Resurfacing;
  • Topical Drugs
03

In context

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Fitzpatrick skin type IV-VI. Local infections or inflammatory disorders.. Neoplasms suspected of being malignant. Allergy to hyaluronic acid, ascorbic acid, and sodium DNA. to fractional CO2 laser. Pregnancy or breastfeeding. Local or systemic adverse reaction
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

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

    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

  • Drugtopical hyaluronic acid, ascorbic acid, and sodium DNA following ablative fractional laser treatment

    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

06

What researchers measure

Primary outcomes

  1. Skin quality

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

    Time frame: From enrollment to the end of treatment at 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

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  • 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. PubMed 8532986 ↗
  • 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. PubMed 33690945 ↗
  • 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. PubMed 11859596 ↗
  • 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. PubMed 37373443 ↗
  • 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
  • Holck DE, Ng JD. Facial skin rejuvenation. Curr Opin Ophthalmol. 2003 Oct;14(5):246-52. doi: 10.1097/00055735-200310000-00004. PubMed 14502051 ↗
  • 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. PubMed 18476794 ↗
  • 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. PubMed 31695467 ↗
  • 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. PubMed 39611591 ↗
  • 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. PubMed 37723352 ↗
  • Weinstein-Oppenheimer CR, Brown DI, Coloma R, Morales P, Reyna-Jeldes M, Diaz MJ, Sanchez 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. Epub 2017 May 17. PubMed 28629085 ↗
  • 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. PubMed 28941321 ↗
  • 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. PubMed 37577796 ↗
  • 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. PubMed 32708202 ↗
  • 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. PubMed 36139737 ↗
  • 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. PubMed 28629001 ↗
  • 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. PubMed 32738399 ↗
  • 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. PubMed 26612341 ↗
  • 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. PubMed 22672633 ↗
  • 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. PubMed 16029672 ↗
  • 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. PubMed 29154501 ↗
  • 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. PubMed 36325715 ↗
  • Waibel JS, Rudnick A. Laser-Assisted Delivery to Treat Facial Scars. Facial Plast Surg Clin North Am. 2017 Feb;25(1):105-117. doi: 10.1016/j.fsc.2016.08.010. PubMed 27888888 ↗
  • 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. PubMed 26073121 ↗
  • 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. PubMed 25549816 ↗
  • 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. PubMed 6358066 ↗
  • 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. PubMed 26389853 ↗
  • 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. PubMed 20166154 ↗
  • Alegre-Sanchez A, Jimenez-Gomez N, Boixeda P. Laser-Assisted Drug Delivery. Actas Dermosifiliogr (Engl Ed). 2018 Dec;109(10):858-867. doi: 10.1016/j.ad.2018.07.008. Epub 2018 Sep 25. English, Spanish. PubMed 30266385 ↗
  • 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. PubMed 24664987 ↗
  • Zaleski-Larsen LA, Fabi SG. Laser-Assisted Drug Delivery. Dermatol Surg. 2016 Aug;42(8):919-31. doi: 10.1097/DSS.0000000000000556. PubMed 27191783 ↗
  • 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. PubMed 36834554 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Abril 2026 - December 2026

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for Feb 2026, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2026
First posted
Jan 29, 2026
StartActual
Nov 7, 2025
Primary completionEst.
Feb 28, 2026
CompletionEst.
Apr 30, 2026
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07376148
Lead sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
Nov 7, 2025
Primary completion
Feb 28, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Jan 29, 2026

Study contacts

Daniel B Mejia Llanes MD, Medical Doctor
Contact
db.mejia@outlook.com
+503 6420 5801

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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