Clinical Trials Logo
  1. Home
  2. Acne Vulgaris
  3. NCT04321070
  4. Details
NCT04321070 Clinical Trial

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:
A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04321070
Other study ID # CLPL 1907
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 9, 2019
Est. completion date March 6, 2020

Study information
Verified date March 2020
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Description:

Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Recruitment information / eligibility
Status Completed
Enrollment 550
Est. completion date March 6, 2020
Est. primary completion date December 14, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy male or non pregnant female aged = 12 and = 40years with a clinical diagnosis of acne vulgaris.

- Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.

- Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

- Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

- Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clindamycin Phosphate
A thin film of investigation product will be applied to the affected areas of the face once daily
• Clindamycin Phosphate RLD
A thin film of investigation product will be applied to the affected areas of the face once daily
• Placebos
A thin film of investigation product will be applied to the affected areas of the face once daily

Locations
Country Name City State
United States Catawba Research LLC Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Demonstration of Bioequivalence Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts Week 12
See also
  Status Clinical Trial Phase
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
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
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 NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT02250430 - A Phase 1 Study Assessing Local Cutaneous Effects of SB204 Phase 1
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 NCT02524665 - 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne Phase 4
Completed NCT01706250 - U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™ Phase 4
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2