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NCT Number: NCT07639151

Effectiveness and Safety of a Hydrating Gel Containing Polyvinyl Pyrrolidine, Algin 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).

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Key information

Conditions

Hydration Carbon-dioxide Laser Hydrogel Laser Therapy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia Hospital

Depok, West Java, Indonesia

Location contact

Irma Bernadette S. Sitohang, Prof. Dr. dr.

CONTACT

[email protected]

+62818130761

Irma Bernadette S. Sitohang, Prof. Dr. dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 18-60 years.
  • 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.
  • 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.
  • Willing to participate in the study and have provided written informed consent after receiving adequate explanation regarding the study.

Exclusion criteria

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

Treatment and study plan

CO2 Fractional Laser

Device

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

Other names: laser treatment

Hydrogel

Other

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

Placebo gel

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Erythema severity

    Time frame: Baseline, immediately after treatment, Day 3, Day 7, and Day 14.

    Change in erythema severity assessed by dermatologist evaluation.

  2. Subjective assessment

    Time frame: Baseline, Immediately after treatment, Day 3, Day 7, and Day 14.

    Anamnesis, VAS (Visual Analog Scale) Score

Study contacts

Contact information is provided by the study sponsor or research team.

Irma Bernadette S. Sitohang, Prof. Dr. dr.

CONTACT

[email protected]

+62818130761

Sponsors and collaborators

Lead sponsor

Dr.dr.Irma Bernadette, SpKK (K)

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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