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

June 5, 2026 updated by: Dr.dr.Irma Bernadette, SpKK (K)

Effectiveness and Safety of a Hydrating Gel Containing Aqua, Carrageenan, Polyvinyl Pyrrolidon, Algin, Gellan Gum, and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • West Java
      • Depok, West Java, Indonesia
        • Universitas Indonesia Hospital
        • Contact:
        • Principal Investigator:
          • Irma Bernadette S. Sitohang, Prof. Dr. dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female participants aged 18-60 years.
  2. Patients attending the Dermatology and Venereology Outpatient Clinic of Universitas Indonesia Hospital (RSUI) who will receive the hydrating gel either following fractional CO₂ laser treatment or without undergoing the fractional CO₂ laser procedure.
  3. Patients who will undergo or have undergone a priming regimen with topical retinoic acid preparations at concentrations of at least 0.025%, 0.05%, or 0.1% for at least 2 weeks prior to fractional CO₂ laser treatment, or prior to study participation in the non-laser group.
  4. Willing to participate in the study and have provided written informed consent after receiving adequate explanation regarding the study.

Exclusion Criteria:

  1. Pregnant, breastfeeding, or currently using oral contraceptives at the time of assessment.
  2. History of systemic retinoid use within the past 3 months.
  3. History of or current treatment for hormonal/endocrine disorders or other serious medical conditions.
  4. Currently receiving immunosuppressive therapy.
  5. Participants who are unable or unwilling to comply with the study protocol and treatment regimen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser + Hydrogel
Participants will undergo fractional CO₂ laser treatment followed by application of the hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid according to the study protocol.
Device: CO2 Fractional Laser
Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.
Other Names:
  • laser treatment
Other: Hydrogel
Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.
Placebo Comparator: Fractional CO₂ Laser + Placebo
Participants will undergo fractional CO₂ laser treatment followed by application of a placebo gel according to the study protocol.
Device: CO2 Fractional Laser
Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.
Other Names:
  • laser treatment
Other: Placebo gel
Placebo gel matched in appearance and application method to the investigational hydrating gel.
Experimental: Hydrating Gel Only
Participants will receive the hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid without fractional CO₂ laser treatment according to the study protocol.
Other: Hydrogel
Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Hydration
Time Frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Skin hydration will be evaluated by measuring skin capacitance using a corneometer.
Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Dermoscopic Assessment of Skin Recovery
Time Frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Dermoscopic evaluation of post-treatment skin changes and recovery.
Baseline, immediately after treatment, Day 3, Day 7, and Day 14.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythema severity
Time Frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Change in erythema severity assessed by dermatologist evaluation.
Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
Subjective assessment
Time Frame: Baseline, Immediately after treatment, Day 3, Day 7, and Day 14.
Anamnesis, VAS (Visual Analog Scale) Score
Baseline, Immediately after treatment, Day 3, Day 7, and Day 14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Collaborators

Indonesian Society of Dermatology and Venereology
College of Dermatologist and Venereologist
Indonesia Medical Education and Research Institute

Investigators

  • Principal Investigator: Irma Bernadette S. Sitohang, Prof. Dr. dr., Universitas Indonesia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hydrogel

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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