Facial InjuriesPhase 2/3NCT07853664
Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue Injuries
A Phase 2/3 study testing Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac in people with Facial Injuries and Pain, run by Thamar University at 1 site in Yemen.
Trial summary
This randomized, controlled clinical trial will evaluate the clinical effects of a topical thermoresponsive hydrogel containing dexamethasone sodium phosphate and diclofenac sodium on postoperative pain and facial swelling in patients undergoing extraoral maxillofacial surgical procedures or primary closure of clean… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Injuries, Pain, Swelling
- What is being tested?
- Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteYemen
- Study dates
- 1 Jan 2026to 1 Jan 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing oral and maxillofacial fracture surgeries involving clean surgical incisions .
- Patients presenting with clean oral and maxillofacial soft tissue injuries due to trauma, suitable for primary closure
- ASA class I-II .
- Willing to comply with postoperative follow-up and consent procedures .
Who cannot join
- Patients with infected, contaminated, or extensive avulsive wounds .
- Wounds requiring secondary healing or grafting .
- Patients with systemic conditions affecting healing (e.g., diabetes, immunosuppression) .
- Patients with known allergy to DEX or DIC .
- Pregnant or lactating females .
- Patients with chronic steroid or NSAID use .
- Active infections at the surgical site .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Alwehdah University Teaching Hospital
Dhamar
Arshad mohammed Almansori, MSc Candidate, 0771697007, arshadalmansori987@gmail.com
About this study
Official title: Clinical Evaluation of a Topical Hydrogel Loaded With Dual Anti-Inflammatory Agents for Postoperative Pain and Swelling Control in Facial Soft Tissue Injuries
This randomized, controlled clinical trial will evaluate the clinical effects of a topical thermoresponsive hydrogel containing dexamethasone sodium phosphate and diclofenac sodium on postoperative pain and facial swelling in patients undergoing extraoral maxillofacial surgical procedures or primary closure of clean facial soft tissue wounds. Participants will be stratified according to fracture status and randomly assigned to receive either the active hydrogel or an identical placebo hydrogel. Pain, facial swelling, wound healing, adverse events, patient satisfaction, and rescue analgesic consumption will be evaluated during the postoperative period.
- Conditions
- Facial Injuries, Pain, Swelling
- Being tested
- Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac, Plain Pluronic F-127 Hydrogel Placebo
- Medical subject headings
- Facial Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poloxmer F-127 Hydrogel with Dexamethasone/DiclofenacDrug
Active topical hydrogel formulation containing dexamethasone and diclofenac for pain and edema control.
Plain Pluronic F-127 Hydrogel PlaceboOther
Blank hydrogel vehicle without active pharmacologic agents.
| Study group | Role | What they receive |
|---|---|---|
| Pluronic Hydrogel Group | Experimental | Topical application of Pluronic F-127 hydrogel loaded with dexamethasone and diclofenac on facial soft tissue wounds. Receives: Drug: Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac |
| Placebo Control Group | Active comparator | Topical application of plain Pluronic F-127 hydrogel base without active ingredients (dexamethasone or diclofenac). Receives: Other: Plain Pluronic F-127 Hydrogel Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Severit
Assessment of pain intensity using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 8 hours, 3 days, and 7 days post-treatment.
Facial Edema
Assessment of facial swelling using the Ristow 5-line anatomic measurement method.
Measured: Baseline, 8 hours, 3 days, and 7 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jan 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thamar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshad Mohammed Abdu abduallah Almansouri, Thamar University
- Investigators
- Nashwan Hamid Al-Tairi, Associate Professor, Principal investigator, Faculty of Dentistry, Thamar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853664
- Sponsor's protocol ID
- EC/FD/2025/014
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No