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Effectiveness and Safety of a Hydrating Gel Containing Polyvinyl Pyrrolidine, Algin and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy

NCT07639151 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-06-10

No results posted yet for this study

Summary

The purpose of this interventional study is to evaluate the effectiveness and safety of a hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid. The study will assess the gel's ability to support optimal skin recovery following fractional CO₂ laser therapy and its effectiveness and safety as a daily adjunctive skincare treatment. Outcomes related to skin hydration, skin barrier function, tolerability, and adverse events will be evaluated throughout the study period.

Female participants aged 18 to 60 years who provide informed consent will be enrolled in this study. Participants will undergo a 2-week priming period with topical tretinoin prior to fractional CO₂ laser treatment. Clinical evaluations will be performed at baseline, immediately after the laser procedure, and on Days 3, 7, and 14 post-treatment. Assessments conducted by a board-certified dermatologist will include dermoscopy, TEWAmeter assessment, erythema assessment, and evaluation of pain and discomfort using a Visual Analog Scale (VAS).

Conditions

  • Hydration
  • Carbon-dioxide Laser
  • Laser Therapy
  • Hydrogel

Interventions

DEVICE

CO2 Fractional Laser

Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.

OTHER

Hydrogel

Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.

OTHER

Placebo gel

Placebo gel matched in appearance and application method to the investigational hydrating gel.

Sponsors & Collaborators

  • Indonesian Society of Dermatology and Venereology

    collaborator UNKNOWN

  • College of Dermatologist and Venereologist

    collaborator UNKNOWN

  • Indonesia Medical Education and Research Institute

    collaborator OTHER

  • Dr.dr.Irma Bernadette, SpKK (K)

    lead OTHER

Principal Investigators

  • Irma Bernadette S. Sitohang, Prof. Dr. dr. · Universitas Indonesia Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-07-31
Completion
2026-09-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07639151 on ClinicalTrials.gov