Carbon-dioxide Laser, Hydration, Hydrogel, Laser Therapy
Conditions
Keywords
Hydrogel, CO2 Fractional Laser, Hydration
Brief 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).
Interventions
DEVICECO2 Fractional Laser
Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.
OTHERHydrogel
Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.
OTHERPlacebo gel
Placebo gel matched in appearance and application method to the investigational hydrating gel.
Sponsors
Dr.dr.Irma Bernadette, SpKK (K)
Indonesian Society of Dermatology and Venereology
College of Dermatologist and Venereologist
Indonesia Medical Education and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants will be randomized into one of three parallel groups: (1) fractional CO₂ laser therapy followed by hydrating gel application, (2) fractional CO₂ laser therapy followed by placebo application, or (3) hydrating gel application without fractional CO₂ laser therapy. Participants will remain in their assigned group throughout the study period and will undergo scheduled assessments at baseline and follow-up visits.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Hydration | Baseline, immediately after treatment, Day 3, Day 7, and Day 14. | Skin hydration will be evaluated by measuring skin capacitance using a corneometer. |
| Dermoscopic Assessment of Skin Recovery | Baseline, immediately after treatment, Day 3, Day 7, and Day 14. | Dermoscopic evaluation of post-treatment skin changes and recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema severity | Baseline, immediately after treatment, Day 3, Day 7, and Day 14. | Change in erythema severity assessed by dermatologist evaluation. |
| Subjective assessment | Baseline, Immediately after treatment, Day 3, Day 7, and Day 14. | Anamnesis, VAS (Visual Analog Scale) Score |
Countries
Indonesia
Contacts
CONTACTIrma Bernadette S. Sitohang, Prof. Dr. dr.
PRINCIPAL_INVESTIGATORIrma Bernadette S. Sitohang, Prof. Dr. dr.
Universitas Indonesia Hospital
Outcome results
None listed