Rosehip seed oil after CO2 laser for the management of facial scars
| ISRCTN | ISRCTN14338385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14338385 |
- Submission date
- 19/11/2024
- Registration date
- 26/11/2024
- Last edited
- 26/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Facial scars are a serious post-surgical complication that needs the attention of the health care system. This type of scars can affect the quality of life and self-esteem of the patient. Therefore, the aim of this study is to evaluate the effectiveness of using rosehip seed oil in the management of facial scars after surgical interventions.
Who can participate?
Adults aged 18 years or older who have a fresh post-surgical facial scar
What does the study involve?
The patients will be randomly assigned to one of the two intervention groups: the silicon cream group or the rosehip seed oil group. Both groups will receive fractional CO2 laser therapy for the management of post-surgical facial scars.
What are the possible benefits and risks of participating?
This study will determine the effectiveness of using rosehip seed oil in the management of facial scars. There is a risk of not achieving optimal results in some cases but the study team can manage these cases with alternative methods.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
January 2024 to November 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Kamar Zwada (zwadakamar@gmail.com)
Contact information
Public, Scientific, Principal Investigator
Damascus, Syria
Damascus
0000
Syria
| Phone | +963 (0)998587787 |
|---|---|
| zwadakamar@gmail.com |
Study information
| Study design | Comparative interventional randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A comparison between silicone cream and rosehip seed oil after the application of fractional CO2 laser in the management of post-surgical facial scars |
| Study objectives | Is there a significant statistical difference between the use of rosehip seed oil and silicon cream after the use of CO2 laser in the management of post-surgical facial scars? |
| Ethics approval(s) |
Approved 22/01/2024, Damascus University Ethics Committee (Damascus, Syria, Damascus, 0000, Syria; +963 (0)113341864; manager@hcsr.gov.sy), ref: 22457 |
| Health condition(s) or problem(s) studied | Facial scar management |
| Intervention | Randomization process: sealed envelope randomization method. Protocol and duration of the treatments: The patients were randomly assigned to one of the two study groups: the control group (silicon cream) and the test group (rosehip seed oil). All patients followed the same protocol, differing only at the final stage. The treatment involved applying a CO2 fractional laser to the scar tissue on the face. Control group (silicon cream): silicon cream was applied to the scar in a thin layer. Test group (rosehip seed oil): 2-3 drops of rosehip seed oil were applied to the scar and spread to cover the entire area. After applying both treatments, an ice bag was used to cool the treated area. Patients in the control group were instructed to apply the silicon cream twice a day for 3 months, while patients in the test group were instructed to apply 2-3 drops of rosehip seed oil to the scar twice a day for 3 months. The fractional laser treatment was reapplied once a month for 3 months. Follow-up: The follow-up session for all patients was scheduled 1 month after the last laser application session. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Scar healing measured using the Vancouver Scar Scale (VSS) to evaluate the pigmentation, elasticity, and height of the scar, evaluated before the treatment and after 4 months |
| Secondary outcome measures | Patient satisfaction measured using a five-point Likert scale at 4 months after the procedure |
| Overall study start date | 07/01/2024 |
| Completion date | 01/11/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Patients are at least 18 years old 2. Fresh atrophic post-surgical facial scar |
| Key exclusion criteria | 1. Matured facial scars (3 months after its formation) 2. Facial scars not caused by facial surgery 3. Patients underwent treatment with retinoid in the last 6 months |
| Date of first enrolment | 01/02/2024 |
| Date of final enrolment | 01/05/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
0000
Syria
Sponsor information
University/education
Damascus, Syria
Damascus
0000
Syria
| Phone | +963 (0)113341864 |
|---|---|
| manager@hcsr.gov.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 10/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the research results |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available on request from Dr Kamar Zwada (zwadakamar@gmail.com) and in the publication related to it after the end of the research. |
Editorial Notes
19/11/2024: Study's existence confirmed by Damascus University.
