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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
CO2 Fractional Laser
DeviceFractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.
Hydrogel
Other interventionHydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.
Placebo gel
Other interventionPlacebo gel matched in appearance and application method to the investigational hydrating gel.
Treatment groups
Trial outcomes
Primary outcomes
Skin Hydration
Skin hydration will be evaluated by measuring skin capacitance using a corneometer.
Dermoscopic Assessment of Skin Recovery
Dermoscopic evaluation of post-treatment skin changes and recovery.
Secondary outcomes
Erythema severity
Change in erythema severity assessed by dermatologist evaluation.
Subjective assessment
Anamnesis, VAS (Visual Analog Scale) Score
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: