Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT01111994
Status:
UNKNOWN
Last Update Posted:
2010-05-20
First Post:
2010-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy & Safety of Clindamycin and Tretinoin in Acne
Sponsor:
Callender Center for Clinical Research
Organization:
Study Overview
Official Title:
Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color
Status:
UNKNOWN
Status Verified Date:
2010-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is ascertain the efficacy and safety of Clindamycin
Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post
Inflammatory Hyperpigmentation in patients with skin of color.
Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post
Inflammatory Hyperpigmentation in patients with skin of color.
Detailed Description:
Acne is a chronic disorder of the pilosebaceous glands characterized by
inflammatory papules, pustules, opened and closed comedones, cysts and
nodules. Post inflammatory hyperpigmentation is a condition in which an
inflammation from a disease such as acne, trauma, or abrasion results in areas
of the skin with increased melanin content compared to the surrounding skin.
There are several treatments available for acne, which include benzoyl
peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin,
tazarotene, adapalene). Combination therapy, such as topical retinoid and
clindamycin, has been shown to be more effective than monotherapy in
addressing all pathogenic factors of acne.
inflammatory papules, pustules, opened and closed comedones, cysts and
nodules. Post inflammatory hyperpigmentation is a condition in which an
inflammation from a disease such as acne, trauma, or abrasion results in areas
of the skin with increased melanin content compared to the surrounding skin.
There are several treatments available for acne, which include benzoyl
peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin,
tazarotene, adapalene). Combination therapy, such as topical retinoid and
clindamycin, has been shown to be more effective than monotherapy in
addressing all pathogenic factors of acne.
Study Oversight
Has Oversight DMC:
False
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?: