Safety and Efficacy of the Use of Botox on Acne

NCT00765375 | Terminated Phase 2 Results DMC

• 1 other identifier: BTX-D-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

• To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)

Conditions

Acne Vulgaris

Keywords

acne; Botox; cosmetic treatments

Outcome Measures

Primary Outcomes (1)

• Change in Mean Lesion Count From Baseline at 90 Days

  To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)

  Baseline and 90 days

Study Arms (1)

Botox and Placebo on each side of face

EXPERIMENTAL

Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)

Drug: Botulinum Neurotoxin Type A; Drug: Bacteriostatic saline

Interventions

Botulinum Neurotoxin Type A DRUG

1.5-3 units of Botox/lesion

Also known as: Botox

Botox and Placebo on each side of face

Bacteriostatic saline DRUG

.1 cc bacteriostatic saline/lesion

Botox and Placebo on each side of face

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the age of 18 and 50 years of age
• Not pregnant and negative pregnancy test, not planning on getting pregnant
• Mild to moderate bilateral acne lesions on the face
• Able to understand the requirements of the study and sign an Informed Consent Form
• Have the time and ability to complete the study and comply with instructions(i.e will be around for the duration of the study)
• Skin types I, II, III, IV and V

You may not qualify if:

• Subject has skin type VI
• Subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or congestive heart disease
• Concurrent skin conditions affecting area to be treated
• Prior exposure to any serotype of botulinum toxin for any purpose in the 3 months immediately prior to study enrollment
• Prior surgery on the area to be treated within 3 months of initial treatment or during this clinical evaluation
• Open laceration, abrasion active cold sores or herpes sores, multiple dysplastic nevi in areas to be treated?
• Permanent or semi-permanent dermal filler treatment within the last 6 months
• Medium or deep depth chemical peel resurfacing procedure within 3 months of treatment or during this clinical evaluation
• Has used oral isotretinoin (Accutane) within 6 months, or use of topical isotretinoin within 3 months, of initial treatment or during this clinical evaluation
• Prior light /laser treatments at target locations within 3 months of enrollment or during the course of this clinical evaluation
• Any physical or mental condition which, in the investigator's opinion would make it unsafe for the subject to participate in the clinical evaluation
• Use of oral antibiotics for acne and/or medication that cause photosensitivity within 2 weeks of initial treatment
• Participation in a study of another investigational devices or drugs within 3 months of enrollment
• Subject shows symptoms of a hormonal disorder
• Subject cannot be treated for (past or present) any form of treatment of active cancer or having a history of skin cancer or any other cancer in the area to be treated

Sponsors & Collaborators

• DeNova Research: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

Study terminated after 5 subjects

Results Point of Contact

• Title: Jack Arkins, Data Manager
• Organization: DeNova Research

jack@drdayan.com

312-335-2070

Study Officials

• Steven H Dayan, MD F.A.C.S.

  DeNova Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 29, 2018
• Results First Posted: April 30, 2015

Record last verified: 2018-05

Locations

US (1)