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Photocil (Topical) for the Treatment of Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992185
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vitiligo
Interventions Drug: Photocil for Vitiligo
Other: Placebo - Sunscreen (SPF 2)
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Photocil for Vitiligo Placebo - Sunscreen (SPF 2)
Hide Arm/Group Description

Active Drug - Photocil for Vitiligo

Photocil for Vitiligo: Photocil for Vitiligo

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)

Period Title: Overall Study
Started 7 8
Completed 7 8
Not Completed 0 0
Arm/Group Title Photocil for Vitiligo Placebo - Sunscreen (SPF 2) Total
Hide Arm/Group Description

Active Drug - Photocil for Vitiligo

Photocil for Vitiligo: Photocil for Vitiligo

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)

Total of all reporting groups
Overall Number of Baseline Participants 7 8 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 8 participants 15 participants
38  (13.4) 35.1  (15.2) 36.5  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 15 participants
Female
3
  42.9%
4
  50.0%
7
  46.7%
Male
4
  57.1%
4
  50.0%
8
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 8 participants 15 participants
7 8 15
1.Primary Outcome
Title Percent Repigmentation
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photocil for Vitiligo Placebo - Sunscreen (SPF 2)
Hide Arm/Group Description:

Active Drug - Photocil for Vitiligo

Photocil for Vitiligo: Photocil for Vitiligo

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)

Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: Percent Repigmentation
48.5  (16.8) 2.5  (7.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Photocil for Vitiligo Placebo - Sunscreen (SPF 2)
Hide Arm/Group Description

Active Drug - Photocil for Vitiligo

Photocil for Vitiligo: Photocil for Vitiligo

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)

All-Cause Mortality
Photocil for Vitiligo Placebo - Sunscreen (SPF 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Photocil for Vitiligo Placebo - Sunscreen (SPF 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Photocil for Vitiligo Placebo - Sunscreen (SPF 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sharon Keene, MD
Organization: Physicians Institute
Phone: (520) 290-5555
EMail: monican@appliedbiology.com
Layout table for additonal information
Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT01992185    
Other Study ID Numbers: AB-DRUG-PHOTOCIL-VT-001
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: December 11, 2015
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016