NCT01243450

Brief Summary

The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
958

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed
Last Updated

January 3, 2020

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 16, 2010

Results QC Date

September 7, 2014

Last Update Submit

December 28, 2019

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

  • Acne Lesion Percent Reduction

    Reduction in number of Acne lesions by counting over 12 weeks

    12 week

Study Arms (3)

Active generic

ACTIVE COMPARATOR

Treatment of acne for 12 weeks with generic tretinoin

Drug: Tretinoin

Placebo

PLACEBO COMPARATOR

Treatment of acne for 12 weeks with Placebo

Drug: placebo

Brand

ACTIVE COMPARATOR

Treatment of acne over 12 weeks with tretinoin Brand

Drug: Tretinoin

Interventions

TretinoinDRUG

Treatment of acne

Also known as: active medication
Active genericBrand
placeboDRUG

treatment of acne

Also known as: inactive medication
Placebo

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Normal, healthy male and female children and adults.
  • Age 12 to 40 years.
  • Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).
  • Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.
  • Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).
  • Global severity score from 2-4
  • Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
  • Considered reliable and capable of understanding their responsibility and role in the study.

You may not qualify if:

  • Subjects with active cystic acne as evidenced by more than 2 facial nodules.
  • More than 40 papules and/or pustules (inflammatory lesions)
  • More than 60 open and or closed comedones/milia (non-inflammatory lesions)
  • Overall severity grade of less than 2 or greater than 4,
  • History of allergy or hypersensitivity to tretinoin.
  • Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
  • Use of systemic retinoid treatment within six months prior to study initiation.
  • Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
  • Pregnant or breast-feeding.
  • Participation in a clinical study for acne within 4 months preceding study initiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cu-Tech, LLC

Mountain Lakes, New Jersey, 07046, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Results Point of Contact

Title
William J. Cunningham, MD
Organization
Cu-Tech, LLC
wcunningham@cu-tech.com
(973) 331-1620

Study Officials

  • William Cunningham, MD

    Cu-Tech

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 18, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 3, 2020

Results First Posted

November 18, 2014

Record last verified: 2014-11

Locations

US(1)