The effectiveness of platelet-rich plasma injection in the treatment of forehead wrinkles
| ISRCTN | ISRCTN45263738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45263738 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | DN-02092024-307 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 03/10/2024
- Registration date
- 04/10/2024
- Last edited
- 04/10/2024
- 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
Wrinkles are considered one of the most common signs of ageing and interventions aimed at treating them are among the most common interventions in cosmetic clinics that pose a challenge to the doctor. A number of materials have been used in treating wrinkles, each of which has advantages and disadvantages. Microneedling has been used in treating wrinkles and skin problems such as pigmentation and scars because it stimulates the formation of collagen. Therefore, this study aimed to increase the effectiveness of microneedling by combining it with platelet-rich plasma injections.
Who can participate?
Women aged 30 - 50 years with forehead wrinkles
What does the study involve?
Participants were randomly divided into two groups. The first group underwent three sessions of microneedling using the Dermapen device with 21-day time intervals between sessions. The second group underwent three sessions of microneedling using the Dermapen device followed by platelet-rich plasma injections with 21-day time intervals between sessions. The results were then compared by a committee of specialists at 6 months after the last intervention.
What are the possible benefits and risks of participating?
The possible benefits are the improvement of wrinkles. There are no expected risks but some pain and edema (swelling) could happen in some cases.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
May 2023 to December 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Ahmad Aleed, ahmadaleed004@gmail.com
Contact information
Public, Scientific, Principal investigator
Damascus
Damascus
12110
Syria
| Phone | +963 (0)968730340 |
|---|---|
| ahmadaleed004@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of the effectiveness of platelet-rich plasma injection after microneedling by Dermapen device in the treatment of forehead wrinkles |
| Study acronym | EPMW |
| Study objectives | Dermpen is effective at treating wrinkles |
| Ethics approval(s) |
Approved 19/05/2023, Damascus University Biomedical Research Ethics Committee (Damascus, Damascus, 12110, Syria; +963 (0)1133923482; ap.srd@damascusuniversity.edu.sy), ref: DN-02092024-307 |
| Health condition(s) or problem(s) studied | Forehead wrinkles |
| Intervention | The research sample was divided into two groups using a coin method. The first group underwent three sessions of microneedling using the Dermapen device with 21-day time intervals between sessions, which is the control group. The second group underwent three sessions of microneedling using the Dermapen device, followed by platelet-rich plasma injections with 21-day time intervals between sessions, which is the study group. The results were then compared by a committee of five specialists at 6 months after the last intervention. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Wrinkle grade is measured using the Allergan Forehead Line scale at baseline and 6 months after the last intervention |
| Key secondary outcome measure(s) |
Improvement measured using the Subject Global Aesthetic Improvement Scale (SGAIS) at baseline and 6 months after the last intervention |
| Completion date | 30/12/2024 |
Eligibility
| Participant type(s) | Patient, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 16 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Female 2. 30 - 50 years |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 25/09/2023 |
| Date of final enrolment | 22/06/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
12110
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/10/2024: Study's existence confirmed by Damascus University Biomedical Research Ethics Committee.
