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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorDr.dr.Irma Bernadette, SpKK (K)

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CO2 Fractional Laser

    Device

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

  • Hydrogel

    Other intervention

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

  • Placebo gel

    Other intervention

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

Treatment groups

51 Participants
are divided into 3 treatment groups
Group A: Laser + HydrogelExperimental treatment 2 interventions
Group B: Fractional CO₂ Laser + PlaceboPlacebo comparator 2 interventions
Group C: Hydrating Gel OnlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Skin Hydration

Skin hydration will be evaluated by measuring skin capacitance using a corneometer.

Time frame
Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
2

Dermoscopic Assessment of Skin Recovery

Dermoscopic evaluation of post-treatment skin changes and recovery.

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

Secondary outcomes

1

Erythema severity

Change in erythema severity assessed by dermatologist evaluation.

Time frame
Baseline, immediately after treatment, Day 3, Day 7, and Day 14.
2

Subjective assessment

Anamnesis, VAS (Visual Analog Scale) Score

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr.dr.Irma Bernadette, SpKK (K)

Lead sponsor

Indonesia University

Sponsor institution

Indonesian Society of Dermatology and Venereology

Collaborator

College of Dermatologist and Venereologist

Collaborator

Indonesia Medical Education and Research Institute

Collaborator

This trial is not recruiting at the moment. You can still explore other options: