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| Name | Class |
|---|---|
| Indonesian Society of Dermatology and Venereology | UNKNOWN |
| College of Dermatologist and Venereologist | UNKNOWN |
| Indonesia Medical Education and Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser + Hydrogel | Experimental | 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. |
|
| Fractional CO₂ Laser + Placebo | Placebo Comparator | Participants will undergo fractional CO₂ laser treatment followed by application of a placebo gel according to the study protocol. |
|
| Hydrating Gel Only | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 Fractional Laser | Device | Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Hydration | 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 | Dermoscopic evaluation of post-treatment skin changes and recovery. | Baseline, immediately after treatment, Day 3, Day 7, and Day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema severity | Change in erythema severity assessed by dermatologist evaluation. | Baseline, immediately after treatment, Day 3, Day 7, and Day 14. |
| Subjective assessment | Anamnesis, VAS (Visual Analog Scale) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irma Bernadette S. Sitohang, Prof. Dr. dr. | Contact | +62818130761 | irma_bernadette@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Irma Bernadette S. Sitohang, Prof. Dr. dr. | Universitas Indonesia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia Hospital | Depok | West Java | Indonesia |
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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.
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| 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. |
|
| Baseline, Immediately after treatment, Day 3, Day 7, and Day 14. |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D020100 | Hydrogels |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D005782 | Gels |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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