Expired Study
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Mountain Lakes, New Jersey 07046


Purpose:

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.


Study summary:

Acne study


Criteria:

A subject will be eligible to participate if they meet all of the following inclusion criteria: - 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. Exclusion Criteria A subject will be eligible to participate if they meet none of the following exclusion criteria: - 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.


Study is Available At:


Original ID:

RAM-04


NCT ID:

NCT01243450


Secondary ID:


Study Acronym:


Brief Title:

Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo


Official Title:

Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Spear Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: B


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

958


Enrollment Type:

Actual


Overall Contact Information

Official Name:William Cunningham, MD
Study Director
Cu-Tech

Study Dates

Start Date:October 2009
Completion Date:October 2010
Completion Type:Actual
Primary Completion Date:October 2010
Primary Completion Type:Actual
Verification Date:November 2014
Last Changed Date:November 17, 2014
First Received Date:November 16, 2010
First Results Date:September 7, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Acne Lesion Percent Reduction
Time Frame:12 week
Safety Issues:False
Description:Reduction in number of Acne lesions by counting over 12 weeks

Study Interventions

Intervention Type:Drug
Name:placebo
Description:treatment of acne
Arm Name:Placebo
Other Name:inactive medication
Intervention Type:Drug
Name:Tretinoin
Description:Treatment of acne
Arm Name:Active generic
Other Name:active medication

Study Arms

Study Arm Type:Active Comparator
Arm Name:Active generic
Description:Treatment of acne for 12 weeks with generic tretinoin
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Treatment of acne for 12 weeks with Placebo
Study Arm Type:Active Comparator
Arm Name:Brand
Description:Treatment of acne over 12 weeks with tretinoin Brand

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Spear Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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