Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-19 @ 10:31 PM
Study NCT ID:
NCT02249767
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
Sponsor:
Spear Pharmaceuticals
Organization:
Study Overview
Official Title:
Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.
Detailed Description:
This was a double-blind, randomized, three-treatment, parallel study conducted at three locations with a single investigator. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.
The assigned study treatment was self-applied topically once daily for 84 consecutive days. Scheduled study visits included:
* Visit 1 (Baseline Visit, Day 0)
* Visit 2 (First Interim Visit, Day 14)
* Visit 3 (Second Interim Visit, Day 28)
* Visit 4 (Third Interim Visit, Day 56)
* Visit 5 (Forth Interim Visit, Day 84)
A window of ± 4 days was considered acceptable for each scheduled visit following the Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the following procedures were performed:
* Counts of inflammatory, non-inflammatory, and nodulocystic lesions
* The Investigator's Global Assessment (IGA)
* Assessment of application site reactions Safety was assessed by the monitoring of AEs and documenting signs and/or symptoms of application site reactions.
The assigned study treatment was self-applied topically once daily for 84 consecutive days. Scheduled study visits included:
* Visit 1 (Baseline Visit, Day 0)
* Visit 2 (First Interim Visit, Day 14)
* Visit 3 (Second Interim Visit, Day 28)
* Visit 4 (Third Interim Visit, Day 56)
* Visit 5 (Forth Interim Visit, Day 84)
A window of ± 4 days was considered acceptable for each scheduled visit following the Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the following procedures were performed:
* Counts of inflammatory, non-inflammatory, and nodulocystic lesions
* The Investigator's Global Assessment (IGA)
* Assessment of application site reactions Safety was assessed by the monitoring of AEs and documenting signs and/or symptoms of application site reactions.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: