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Status unknownNCT05813483Updated Apr 14, 2023

A Clinical Study to Evaluate the Efficacy and Satisfaction of the Skinceuticals Skin Care Product (CE) for Skin Repair Post Fraxel Laser Treatment

An interventional study of Skinceuticals skin care product(CE) and fraxel laser therapy in Photo-damaging, sponsored by DeYi Aesthetic Medical Clinic. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by DeYi Aesthetic Medical Clinic · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of the Skinceuticals skin care product (CE) for skin repair following fraxel laser treatment and explore the medical value of fraxel laser therapy combined with Skinceuticals skin care product

02

Conditions studied

  • Photo-damaging
03

In context

Lead sponsor

DeYi Aesthetic Medical Clinic is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Chinese subjects aged 18-65 years (inclusive);
  2. Subjects with Fitzpatrick skin type II-IV;
  3. Subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment;
  4. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
  5. Subjects understand the nature of the study and sign the informed consent form (ICF).

Exclusion criteria

Exclusion Criteria:

  1. Subjects with photosensitive skin or photosensitization-related diseases;
  2. Subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives);
  3. Subjects with hypertrophic scar or scar constitution;
  4. Subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes;
  5. Subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment;
  6. Subjects with a history of sun exposure within 2 weeks prior to enrollment;
  7. Subjects who are known to be contraindicated to fraxel laser therapy or CE (or allergic to other skin care components);
  8. Subjects with known infection and inflammation in the intended treatment site;
  9. Female subjects who are pregnant, lactating or plan to become pregnant;
  10. Subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment;
  11. Subjects who are participating in other drug or medical device clinical trials;
  12. Other subjects who are not suitable for this study as assessed by the investigator
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Test group

    fraxel laser therapy combined with Skinceuticals skin care product(CE) and routine moisturizing and sun protection

    Other: Skinceuticals skin care product(CE) · Other: fraxel laser therapy

  • Other
    Control group

    fraxel laser therapy combined with routine moisturizing and sun protection

    Other: fraxel laser therapy

Interventions

  • OtherSkinceuticals skin care product(CE)

    fraxel laser therapy combined with Skinceuticals skin care product(CE) and routine moisturizing and sun protection

  • Otherfraxel laser therapy

    fraxel laser therapy combined with routine moisturizing and sun protection

06

What researchers measure

Primary outcomes

  1. Change in erythema score

    Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)

    Time frame: at day 7 post-procedure

Secondary outcomes

  1. Change from baseline in erythema score

    Scoring criteria: 0 (no erythema), 1 (mild erythema), 2 (moderate erythema), and 3 (severe erythema)

    Time frame: days 1, 3, 5 post-procedure

  2. Change from baseline in edema score

    Score 0 - no edema, score 1 - mild edema, score 2 - moderate edema, score 3 - severe edema

    Time frame: days 1, 3, 5 ,7 post-procedure

  3. Change from baseline in Erythema Index (EI)

    Time frame: days 1, 3, 5 ,7 post-procedure

  4. Change from baseline in melanin index(MI) Change from baseline in melanin index(MI)

    Time frame: days 1, 3, 5 ,7 post-procedure

  5. Change from baseline in stratum corneum water content

    Time frame: days 1, 3, 5 ,7 post-procedure

  6. Change from baseline in transepidermal water loss

    Time frame: days 1, 3, 5 ,7 post-procedure

  7. Change from baseline in sebum rate

    Time frame: days 1, 3, 5 ,7 post-procedure

  8. Subjects overall satisfaction

    Satisfaction ratings were classified as: very satisfied, satisfied, dissatisfied, very dissatisfied

    Time frame: days 1, 3, 5 ,7 post-procedure

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05813483
Lead sponsor
DeYi Aesthetic Medical Clinic
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Apr 17, 2023 (estimated)
Primary completion
Sep 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 14, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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