NCT07397520

Brief Summary

To determine the effectiveness of intralesional 5-fluorouracil in objectively reversing hypertrophic scars in the periocular region resulting from trauma or cosmetic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

February 2, 2026

Last Update Submit

June 22, 2026

Conditions

Facial Scarring

Keywords

5-FUFibrotic ScarFacial Scarring

Outcome Measures

Primary Outcomes (1)

  • Reduction in the size of facial hypertrophic scars

    To objectively assess baseline status and subsequent changes in facial skin, the validated photometric visual scale from Manchester, designed for evaluating scar quality, will be employed. This scale assesses six skin parameters, including coloration, contour, distortion, texture, and brightness, assigning values from 1 to 4, where 1 represents the most favorable characteristic and 4 the least desirable

    From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Intralesional administration of 5-fluorouracil will be conducted in the periocular scar group

EXPERIMENTAL

For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable.

Drug: Intralesional administration of 5-fluorouracil

Interventions

Intralesional administration of 5-fluorouracilDRUG

For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable

Intralesional administration of 5-fluorouracil will be conducted in the periocular scar group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants aged ≥18 years.
  • Presence of a facial scar in the periocular region secondary to trauma or facial cosmetic surgery.
  • Ability and willingness to provide written informed consent.
  • Signed informed consent form prior to participation.

You may not qualify if:

  • Presence of active local infection in the periocular region.
  • Active inflammatory dermatologic or ocular disorders in the treatment area.
  • Known allergy or hypersensitivity to 5-fluorouracil.
  • Pregnancy or breastfeeding.
  • Inability to comply with follow-up visits.
  • Withdrawal of consent during the study.
  • Development of significant local or systemic adverse reactions during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, Mexico City, 06800, Mexico

Location

Related Publications (18)

  • 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.

    PMID: 8532986RESULT

  • Kim S, Woo YR, Cho SH, Lee JD, Kim HS. Clinical Efficacy of 5-Fluorouracil and Bleomycin in Dermatology. J Clin Med. 2024 Jan 6;13(2):335. doi: 10.3390/jcm13020335.

    PMID: 38256469RESULT

  • Tuan TL, Nichter LS. The molecular basis of keloid and hypertrophic scar formation. Mol Med Today. 1998 Jan;4(1):19-24. doi: 10.1016/S1357-4310(97)80541-2.

    PMID: 9494966RESULT

  • Slemp AE, Kirschner RE. Keloids and scars: a review of keloids and scars, their pathogenesis, risk factors, and management. Curr Opin Pediatr. 2006 Aug;18(4):396-402. doi: 10.1097/01.mop.0000236389.41462.ef.

    PMID: 16914994RESULT

  • Rabello FB, Souza CD, Farina Junior JA. Update on hypertrophic scar treatment. Clinics (Sao Paulo). 2014 Aug;69(8):565-73. doi: 10.6061/clinics/2014(08)11.

    PMID: 25141117RESULT

  • Pinedo HM, Peters GF. Fluorouracil: biochemistry and pharmacology. J Clin Oncol. 1988 Oct;6(10):1653-64. doi: 10.1200/JCO.1988.6.10.1653.

    PMID: 3049954RESULT

  • Ogawa R, Akaishi S, Kuribayashi S, Miyashita T. Keloids and Hypertrophic Scars Can Now Be Cured Completely: Recent Progress in Our Understanding of the Pathogenesis of Keloids and Hypertrophic Scars and the Most Promising Current Therapeutic Strategy. J Nippon Med Sch. 2016;83(2):46-53. doi: 10.1272/jnms.83.46.

    PMID: 27180789RESULT

  • Longley DB, Harkin DP, Johnston PG. 5-fluorouracil: mechanisms of action and clinical strategies. Nat Rev Cancer. 2003 May;3(5):330-8. doi: 10.1038/nrc1074.

    PMID: 12724731RESULT

  • Lee HJ, Jang YJ. Recent Understandings of Biology, Prophylaxis and Treatment Strategies for Hypertrophic Scars and Keloids. Int J Mol Sci. 2018 Mar 2;19(3):711. doi: 10.3390/ijms19030711.

    PMID: 29498630RESULT

  • Ogawa R. Keloid and Hypertrophic Scars Are the Result of Chronic Inflammation in the Reticular Dermis. Int J Mol Sci. 2017 Mar 10;18(3):606. doi: 10.3390/ijms18030606.

    PMID: 28287424RESULT

  • Haurani MJ, Foreman K, Yang JJ, Siddiqui A. 5-Fluorouracil treatment of problematic scars. Plast Reconstr Surg. 2009 Jan;123(1):139-148. doi: 10.1097/PRS.0b013e3181904d1b.

    PMID: 19116547RESULT

  • Goldan O, Weissman O, Regev E, Haik J, Winkler E. Treatment of postdermabrasion facial hypertrophic and keloid scars with intralesional 5-Fluorouracil injections. Aesthetic Plast Surg. 2008 Mar;32(2):389-92. doi: 10.1007/s00266-007-9109-3.

    PMID: 18185952RESULT

  • Limandjaja GC, Niessen FB, Scheper RJ, Gibbs S. Hypertrophic scars and keloids: Overview of the evidence and practical guide for differentiating between these abnormal scars. Exp Dermatol. 2021 Jan;30(1):146-161. doi: 10.1111/exd.14121. Epub 2020 Jul 6.

    PMID: 32479693RESULT

  • Diasio RB, Harris BE. Clinical pharmacology of 5-fluorouracil. Clin Pharmacokinet. 1989 Apr;16(4):215-37. doi: 10.2165/00003088-198916040-00002.

    PMID: 2656050RESULT

  • Atiyeh BS. Nonsurgical management of hypertrophic scars: evidence-based therapies, standard practices, and emerging methods. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):468-92; discussion 493-4. doi: 10.1007/s00266-006-0253-y. Epub 2007 Jun 18.

    PMID: 17576505RESULT

  • Ehrlich HP, Desmouliere A, Diegelmann RF, Cohen IK, Compton CC, Garner WL, Kapanci Y, Gabbiani G. Morphological and immunochemical differences between keloid and hypertrophic scar. Am J Pathol. 1994 Jul;145(1):105-13.

    PMID: 8030742RESULT

  • Jiang ZY, Liao XC, Liu MZ, Fu ZH, Min DH, Yu XT, Guo GH. Efficacy and Safety of Intralesional Triamcinolone Versus Combination of Triamcinolone with 5-Fluorouracil in the Treatment of Keloids and Hypertrophic Scars: A Systematic Review and Meta-analysis. Aesthetic Plast Surg. 2020 Oct;44(5):1859-1868. doi: 10.1007/s00266-020-01721-2. Epub 2020 Apr 27.

    PMID: 32342167RESULT

  • Shah VV, Aldahan AS, Mlacker S, Alsaidan M, Samarkandy S, Nouri K. 5-Fluorouracil in the Treatment of Keloids and Hypertrophic Scars: A Comprehensive Review of the Literature. Dermatol Ther (Heidelb). 2016 Jun;6(2):169-83. doi: 10.1007/s13555-016-0118-5. Epub 2016 Apr 22.

    PMID: 27105629RESULT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intralesional administration of 5-fluorouracil will be conducted in the periocular scar. For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

August 1, 2025

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
From November to December 2026

Locations

ME(1)