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Photocil (Topical) for the Treatment of Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01992172
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : March 25, 2016
Last Update Posted : March 25, 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: Atopic Dermatitis
Interventions: Drug: Photocil for Atopic Dermatitis
Other: Placebo - Sunscreen (SPF 2)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Photocil for Atopic Dermatitis

Active Drug - Photocil for Atopic Dermatitis

Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2)

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


Participant Flow:   Overall Study
    Photocil for Atopic Dermatitis   Placebo - Sunscreen (SPF 2)
STARTED   7   0 
COMPLETED   7   0 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Photocil for Atopic Dermatitis

Active Drug - Photocil for Atopic Dermatitis

Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis

Placebo - Sunscreen (SPF 2)

Placebo - Sunscreen (SPF 2)

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

Total Total of all reporting groups

Baseline Measures
   Photocil for Atopic Dermatitis   Placebo - Sunscreen (SPF 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   0   7 
Age 
[Units: Participants]
     
<=18 years   0      0 
Between 18 and 65 years   7      7 
>=65 years   0      0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.3  (5.29)      32.3  (5.29) 
Gender 
[Units: Participants]
     
Female   7      7 
Male   0      0 
Region of Enrollment 
[Units: Participants]
     
United States   7      7 


  Outcome Measures

1.  Primary:   Number of Pruritus Events in Last 30 Days   [ Time Frame: 30 days from baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sharon Keene, MD
Organization: Physicians Institute
phone: (520) 290-5555
e-mail: monican@appliedbiology.com



Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT01992172     History of Changes
Other Study ID Numbers: AB-DRUG-PHOTOCIL-AD-001
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: December 11, 2015
Results First Posted: March 25, 2016
Last Update Posted: March 25, 2016