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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)
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Photocil for Atopic Dermatitis Placebo - Sunscreen (SPF 2)
Hide Arm/Group Description

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)

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

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)

Total of all reporting groups
Overall Number of Baseline Participants 7 0 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 7 participants
<=18 years 0 0
Between 18 and 65 years 7 7
>=65 years 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 0 participants 7 participants
32.3  (5.29) 32.3  (5.29)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 7 participants
Female 7 7
Male 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 0 participants 7 participants
7 7
1.Primary Outcome
Title Number of Pruritus Events in Last 30 Days
Hide Description [Not Specified]
Time Frame 30 days from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Photocil for Atopic Dermatitis Placebo - Sunscreen (SPF 2)
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 7 0
Mean (Standard Deviation)
Unit of Measure: Events
Baseline 7.4  (2.9)
90 Day 1.9  (1.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Photocil for Atopic Dermatitis Placebo - Sunscreen (SPF 2)
Hide Arm/Group Description

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)

All-Cause Mortality
Photocil for Atopic Dermatitis Placebo - Sunscreen (SPF 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Photocil for Atopic Dermatitis Placebo - Sunscreen (SPF 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Photocil for Atopic Dermatitis Placebo - Sunscreen (SPF 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/0 
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
Name/Title: Sharon Keene, MD
Organization: Physicians Institute
Phone: (520) 290-5555
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