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Randomized Controlled Trial Evaluating the Efficacy and Safety of Botulinum Toxin Type A, Topical Dihydromyricetin, and Their Combination in Periorbital Rejuvenation: A Pilot Study

Randomized Controlled Trial Evaluating the Efficacy and Safety of Botulinum Toxin Type A, Topical Dihydromyricetin, and Their Combination in Periorbital Rejuvenation: A Pilot Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260616012
Enrollment
60
Registered
2026-06-16
Start date
2026-06-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Photoaging Photoaging, Laxity

Interventions

Participants randomized to the botulinum toxin group will receive botulinum toxin type A (CCUG 7968 strain) injections for the treatment of crows feet at a dose of 10 units per side.,Participants rand
Botulinum toxin type A injection,Topical dihydromyricetin-containing serum,Combination treatment

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged 30to 45 years. 2. Presence of moderate or greater crows feet wrinkles, as assessed using the Merz 5 Point Crows Feet Scale. 3. Thai individuals of Asian ethnicity with Fitzpatrick skin types III to V.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Participants with neuromuscular disorders, such as amyotrophic lateral sclerosis (ALS), myopathies, myasthenia gravis, or any other condition deemed unsafe by the investigator. 3. History of hypersensitivity or allergy to dihydromyricetin and/or botulinum toxin. 4. Use of oral isotretinoin or topical retinoids within 6 months prior to study enrollment. 5. History of botulinum toxin injection, dermal filler injection, platelet-rich plasma (PRP) injection, chemical peeling, skin tightening procedures, laser treatment, or thread lifting of the face within 6 months prior to study enrollment. 6. Use of oral or topical whitening agents, or oral antioxidant supplements within 3 months prior to study enrollment. 7. History of platelet disorders, coagulation abnormalities, anemia, liver disease, malignancy, autoimmune disorders, diabetes mellitus, or use of antiplatelet or anticoagulant medications, as well as any medical condition considered by the investigator to pose a safety risk (e.g., epilepsy). 8. Current smokers or individuals with a history of excessive alcohol consumption. 9. History of hypertrophic scars or keloids. 10. Presence of other dermatologic conditions in the treatment area, including skin infections or active dermatitis. 11. Diagnosed psychiatric disorders confirmed by a psychiatrist. 12. Refusal to undergo photography for treatment evaluation.

Design outcomes

Primary

MeasureTime frame
Merz 5-point scale for crow's feet Baseline, 1, 2, 3, 4, 5 and 6 months after treatment Blinded physician assessment,Safety 1, 2, 3, 4, 5 and 6 months after treatment Adverse events

Secondary

MeasureTime frame
Participants improvement scale 1, 2, 3, 4, 5 and 6 months after treatment Quartile scale,Skin quality Baseline, 1, 2, 3, 4, 5 and 6 months after treatment Antera 3D

Countries

Thailand

Contacts

Public ContactRungsima Wanitphakdeedecha

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

rungsima.wan@mahidol.ac.th024194333

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026