A split-face study comparing intradermal botulinum toxin A with and without hyaluronic acid biorevitalization for facial rejuvenation
| ISRCTN | ISRCTN14932955 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14932955 |
| Secondary identifying numbers | Mutah University IRB Approval Number 70025 |
- Submission date
- 16/10/2025
- Registration date
- 20/10/2025
- Last edited
- 20/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study looks at a new way of improving facial skin quality and reducing wrinkles. Botulinum toxin type A (commonly known as BoNT-A) is already widely used to soften facial lines, while hyaluronic acid–based products can improve hydration, firmness, and radiance of the skin. This study will test whether combining both treatments in a single injection session works better than BoNT-A alone.
Who can participate?
Healthy adults between 35 and 55 years old who show early signs of skin aging, such as fine lines, wrinkles, or mild skin laxity.
What does the study involve?
Each participant receives treatment on both sides of the face in a “split-face” design. One side is treated with BoNT-A alone, while the other side is treated with BoNT-A mixed with a hyaluronic acid–based product (NCTF®135HA). The injections are given using very fine needles in small amounts. Participants are then followed up for 60 days to assess changes in wrinkles, skin hydration, tone, and overall appearance. Photos and questionnaires are also used to measure results.
What are the possible benefits and risks of participating?
The potential benefits include visible improvement in facial skin quality and wrinkle reduction. Risks are minimal but may include temporary redness, bruising, swelling, or mild discomfort at the injection site. These are expected to resolve naturally.
Where is the study run from?
The study is carried out at Mutah University Faculty of Medicine and a private facial plastic surgery clinic in Amman, Jordan.
When is the study starting and how long is it expected to run for?
The study began in July 2024 and is expected to run until February 2025, including treatment and follow-up visits.
Who is funding the study?
Investigator-initiated and funded.
Who is the main contact?
Dr Islam Alzayadneh, Assistant Professor, Department of Otolaryngology–Head & Neck Surgery, Mutah University, Karak, Jordan, izayadne@mutah.edu.jo, xayadneislam@gmail.com
Contact information
Public, Scientific, Principal Investigator
Jabal Amman Albasma medical complex 4th floor
Amman
11189
Jordan
 ORCID ID |
0009-0006-6514-4744 |
|---|---|
| Phone | +962 0791846463 |
| izayadne@mutah.edu.jo |
Study information
| Study design | Single-centre interventional prospective randomized double-blind intra-patient split-face trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other therapist office, University/medical school/dental school |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | 48210_PIS.pdf |
| Scientific title | Streamlined facial rejuvenation: a randomized split-face trial of premixed intradermal botulinum toxin type A and hyaluronic acid biorevitalization |
| Study acronym | BRIGHT-FACE SFR Trial |
| Study objectives | To evaluate the efficacy and safety of a single-session premixed intradermal botulinum toxin type A (BoNT-A) with hyaluronic acid biorevitalization (NCTF®135HA) compared to BoNT-A alone in improving wrinkle severity and skin quality parameters in adults |
| Ethics approval(s) |
Approved 24/09/2025, Mutah University Faculty of Medicine Ethics Committee (Street, Mu'tah, Alkarak, 61710, Jordan; +962-3 2372380-99; abu_lubbad@mutah.edu.jo), ref: 70025 |
| Health condition(s) or problem(s) studied | Facial aging (dynamic wrinkles, skin quality deterioration) |
| Intervention | Participants are randomized using a computer-generated random sequence in a split-face design, with one side of the face receiving intradermal botulinum toxin type A (BoNT-A) monotherapy and the contralateral side receiving a premixed formulation of BoNT-A with NCTF®135HA combination. Allocation was concealed by an independent staff member not involved in injections or evaluations. BoNT-A (20 Units of Dysport® per side, reconstituted to 20 U/mL) is administered intradermally using the microdroplet technique. For the combination side, BoNT-A is premixed with 0.9 mL of NCTF®135HA to maintain an identical BoNT-A concentration. Microinjections of 0.01–0.05 mL per droplet are delivered in a 1 cm² grid across the forehead, periorbital region, perioral lines, and nasolabial folds using a 32-gauge needle. The intervention is performed in a single session under topical anesthesia. Outcomes are assessed at baseline and 60 days post-treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The change in wrinkle severity scores, comparing BoNT-A monotherapy versus BoNT-A + NCTF®135HA (split-face design), will be measured using the Wrinkle Severity Rating Scale (WSRS) between baseline (Day 0) and Day 60 |
| Secondary outcome measures | 1. The change in hydration, firmness, radiance, and tone homogeneity will be patient- and evaluator-reported using a Visual Analog Scale (VAS) from baseline to Day 60 2. Global aesthetic improvement in appearance will be measured by a blinded evaluator and patient using the Global Aesthetic Improvement Scale (GAIS) at Day 60 for each treatment side 3. The proportion of participants reporting visible side-to-side differences, satisfaction, willingness to repeat treatment, and likelihood of recommending it will be measured using a patient satisfaction questionnaire at Day 60 4. The incidence and type of treatment-related adverse events (e.g., bruising, swelling, erythema, tightness) will be measured using case report forms up to Day 60 |
| Overall study start date | 01/07/2024 |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 52 |
| Total final enrolment | 52 |
| Key inclusion criteria | 1. Adults aged 35 to 55 years 2. Presence of mild to moderate dynamic facial wrinkles (e.g., forehead, periorbital, perioral, or nasolabial folds) 3. Early signs of skin laxity and reduced dermal quality (e.g., hydration, tone, or radiance) 4. Willingness to refrain from other facial aesthetic treatments during the study period 5. Ability and willingness to provide written informed consent |
| Key exclusion criteria | 1. Prior facial aesthetic procedures (botulinum toxin, dermal fillers, laser, or energy-based devices) within the past 6 months 2. Active dermatological conditions affecting the face (e.g., eczema, psoriasis, acneiform eruptions, or infections) 3. Known hypersensitivity or allergy to botulinum toxin type A or hyaluronic acid–based products 4. Neuromuscular disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) 5. History of bleeding disorders or current use of anticoagulant/antiplatelet therapy that may increase injection-related risk 6. Pregnancy or breastfeeding 7. Any systemic illness or unstable medical condition judged by investigators to pose a safety concern or interfere with study outcomes 8. Inability or unwillingness to provide informed consent |
| Date of first enrolment | 15/07/2024 |
| Date of final enrolment | 28/02/2025 |
Locations
Countries of recruitment
- Jordan
Study participating centres
alkarak
61710
Jordan
Amman
11189
Jordan
Sponsor information
University/education
Mutah
Karak
61710
Jordan
| Phone | +962 03 2372380 |
|---|---|
| Unit_admin@mutah.edu.jo | |
| Website | https://www.mutah.edu.jo |
"ROR" |
https://ror.org/008g9ns82 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results of this study are intended for publication in a peer-reviewed scientific journal specializing in aesthetic medicine and facial plastic surgery. Findings may also be presented at national and international scientific meetings and conferences. A lay summary will be shared with participants upon request. |
| IPD sharing plan | Individual participant data (IPD) will not be publicly shared due to cultural sensitivities and strict privacy considerations specific to the patient population, as well as the terms of our institutional ethics approval. The IRB-approved consent covered data use for analysis within this trial but did not extend to broader data sharing. Only aggregated, de-identified data are included in the published manuscript. Interested researchers may contact the corresponding author for further information about the study methodology: Dr Islam Alzayadneh, Assistant Professor, Department of Otolaryngology–Head & Neck Surgery, Mutah University, Karak, Jordan, izayadne@mutah.edu.jo, xayadneislam@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 20/10/2025 | No | Yes | ||
| Protocol file | 20/10/2025 | No | No | ||
| Statistical Analysis Plan | 20/10/2025 | No | No |
Additional files
Editorial Notes
17/10/2025: Study's existence confirmed by the Mutah University Faculty of Medicine Ethics Committee, Jordan. The enrolment of the first patient occurred before the formal issuance of the IRB approval due to an administrative lag in document finalization. However, ethical approval had been verbally granted by the university committee before recruitment. The formal approval document was later issued to align with institutional requirements.
