Acne Vulgaris Clinical Trial
Official title:
Comparison of Safety and Efficacy of Tazarotene 0.1% Plus Clindamycin 1% Gel vs. Adapalene 0.1% Plus Clindamycin 1% Gel in the Treatment of Facial Acne Vulgaris: A Randomized Controlled Trial
The combination therapy of retinoid and clindamycin for acne is preferred because it targets multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby improving outcome. Literature review reveals that till date there is no published comparative study assessing safety and efficacy of tazarotene plus clindamycin and adapalene plus clindamycin. So the present study has been designed to compare these two combination therapy in acne vulgaris.
Acne vulgaris is one of the most common disorders treated by dermatologists. The
pathogenesis of acne is multifactorial. Critical components include abnormal follicular
keratinocyte desquamation leading to the formation of a follicular plug (microcomedo),
increase of sebum production in pilosebaceous unit, colonization by Propionibacterium acnes,
and inflammation. Topical retinoids, which target comedogenesis and have anti-inflammatory
activity, are recommended as first-line therapy for both inflammatory and non-inflammatory
acne. The adjunctive use of anti-acne agents like clindamycin by its complementary mechanism
of action can help to enhance the efficacy of topical retinoid therapy still further.
Tazarotene is a synthetic retinoid and a prodrug that is converted by the skin to its active
form, tazarotenic acid. The active form binds to retinoic acid receptors (RARs) and
regulates gene transcription and helps to normalize the abnormal keratinization in the
follicular infundibulum, this in turn changes the microenvironment of the follicle and
thereby reduce the proliferation of Propionibacterium acnes. Adapalene is a synthetic
naphthoic acid derivative with retinoid activity. Adapalene also acts through RARs and
modulates cellular keratinization and inflammatory process. Clindamycin is bactericidal to
Propionibacterium acnes. Due to the inhibition of P. acnes the free fatty acid levels in the
pilosebaceous unit of skin is also reduced. Clindamycin phosphate applied topically
penetrates to a very great extent to open comedones and thus produces a high percentage of
sterile comedones.
The combination therapy of retinoid and clindamycin for acne is preferred because it targets
multiple areas of acne pathogenesis that could not be accomplished with monotherapy, thereby
improving outcome. Literature review reveals that till date there is no published
comparative study assessing safety and efficacy of tazarotene plus clindamycin and adapalene
plus clindamycin. So the present study has been designed to compare these two combination
therapy in acne vulgaris.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04321070 -
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
|
Phase 1 | |
| Recruiting |
NCT05755256 -
The Impact of Probiotics on Skin Hydration in Youth With Mild Acne
|
Phase 2 | |
| Completed |
NCT05131373 -
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
|
Phase 1 | |
| Completed |
NCT01445301 -
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
|
Phase 3 | |
| Completed |
NCT03303170 -
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
|
N/A | |
| Completed |
NCT04698239 -
Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions.
|
N/A | |
| Completed |
NCT02886715 -
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Terminated |
NCT02924428 -
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
|
N/A | |
| Not yet recruiting |
NCT02535871 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Not yet recruiting |
NCT02525822 -
Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
|
Phase 2 | |
| Completed |
NCT02709902 -
Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris
|
Phase 1 | |
| Not yet recruiting |
NCT02491060 -
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
|
Phase 3 | |
| Completed |
NCT02250430 -
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
|
Phase 1 | |
| Completed |
NCT02913001 -
The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
|
N/A | |
| Completed |
NCT01694810 -
Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01769664 -
A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris
|
Phase 1 | |
| Completed |
NCT01727440 -
Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment
|
N/A | |
| Completed |
NCT01194375 -
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
|
Phase 2 | |
| Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 | |
| Completed |
NCT02524665 -
8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
|
Phase 4 |