EUCTR2014-001860-36-IE
Active, not recruiting
Phase 1
Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides
ConditionsFacial Rhytides (Forehead Lines, Glabellar Lines)MedDRA version: 18.1Level: LLTClassification code 10048043Term: WrinklingSystem Organ Class: 100000004858Therapeutic area: Not possible to specify
DrugsBOTOX®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Facial Rhytides (Forehead Lines, Glabellar Lines)
- Sponsor
- Allergan Limited
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •male or female, 18 years of age or older
- •horizontal, symmetrical FHL of moderate to severe rating at maximum eyebrow elevation as assessed by both the subject and the investigator using the FWS at day 1 prior to study treatment; investigator and subject baseline FHL ratings at maximum eyebrow elevation must be identical
- •GL of moderate to severe rating at maximum frown as assessed by the investigator using the FWS at day 1 prior to study treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 320
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 80
Exclusion Criteria
- •prior exposure to botulinum toxin of any serotype for any reason
- •any of the following procedures or treatments occurring in the specified period prior to enrollment (day 1\)
- •\- 3 months: any facial nonablative resurfacing laser or light treatment, microdermabrasion, or superficial peels
- •\- 6 months: any facial cosmetic procedure with medium depth or deep depth facial chemical peels (eg, trichloroacetic acid and phenol); periorbital, midfacial, or upper facial skin resurfacing; or permanent make\-up in the midfacial (extending from inferior orbital margin to level of the nasal base) or upper facial areas
- •\- 12 months: any periorbital, midfacial, or upper facial treatment with nonpermanent soft tissue fillers, or treatment with oral retinoids
- •prior periorbital surgery, facial lift (full\-face or mid\-face), thread lift, eyebrow lift, or related procedures (eg, eyelid \[blepharoplasty] and/or eyebrow surgery)
- •prior periorbital, midfacial, or upper facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore\-Tex®), and/or autologous fat transplantation
- •marked periocular and eyebrow asymmetry assessed by the investigator at maximum contraction (maximum eyebrow elevation for FHL and maximum frown for GL) or rest
- •marked dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or the inability to substantially lessen facial lines even by physically spreading them apart, as determined by the investigator
- •any eyebrow ptosis or eyelid ptosis at baseline, or excessive forehead and eyebrow skin laxity, as determined by the investigator
Outcomes
Primary Outcomes
Not specified
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