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PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933774
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jung Min Bae, The Catholic University of Korea

Brief Summary:
A randomized controlled split-face pilot study was planned to investigate the preventive effect of tretinoin 0.05% cream on hyperpigmentation during phototherapy in patients with vitiligo.

Condition or disease Intervention/treatment Phase
Vitiligo Drug: Tretinoin 0.05% cream Drug: Placebo cream Not Applicable

Detailed Description:
Vitiligo is a chronic depigmentation disorder characterized by well-demarcated white macules and patches, reflecting selective melanocyte destruction. Hyperpigmentation at the treated areas is one of the limitations of phototherapy. Topical tretinoin (retinoic acid) has been well established to be effective for skin pigmentary disorders including melasma. This study aims to investigate the preventive effect of topical tretinoin on hyperpigmentation during phototherapy. A randomized controlled trial based on split-face was planned. The left/right face will be randomized to either tretinoin or placebo cream treatment groups. All lesions will be treated using phototherapy twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : April 29, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
Drug Information available for: Tretinoin

Arm Intervention/treatment
Experimental: Tretinoin 0.05% cream group
Tretinoin 0.05% cream 25g for 1 month, applied once a day every night
Drug: Tretinoin 0.05% cream
Stieva-A Cream 0.05%, 25g, GSK

Active Comparator: Placebo cream group
PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied once a day every night
Drug: Placebo cream
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel




Primary Outcome Measures :
  1. The hyperpigmentation rate (change from baseline) [ Time Frame: At 4weeks, 8weeks, and 12 weeks ]
    The degree of hyperpigmentation will be assessed as % from baseline by using a computer program.

  2. The post-treatment re-pigmentation rate of skin lesion with vitiliginous patch in all patients (change from baseline) [ Time Frame: At 4weeks, 8weeks, and 12 weeks ]
    The assessment of post-treatment re-pigmentation degree in each patient's skin lesion (from baseline by using a computer program)


Secondary Outcome Measures :
  1. The adverse effects [ Time Frame: At 4weeks, 8weeks, and 12 weeks ]
    Irritation or burning sensation, and any other discomforts

  2. The repigmentation (change from baseline) in vitiliginous patches [ Time Frame: At 4weeks, 8weeks, and 12 weeks ]
    The degree of repigmentation will be assessed to investigate the tretinoin cream does not affect the treatment outcome of phototherapy in vitiliginous patches.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: older than 19
  • A patient with stable non-segmental vitiligo
  • A patient with symmetrical vitiligo lesions on face
  • A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
  • A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

  • Age: lower than 20
  • A pregnant or lactating patient
  • A patient with active or spreading vitiligo
  • A patient who cannot understand the study or who does not sign the informed consent
  • Women of childbearing potential not using an effective method of contraception properly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933774


Contacts
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Contact: Jung Min Bae, MD, PhD 82-31-881-8970 ext 8970 jminbae@gmail.com

Locations
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Korea, Republic of
St. Vincent's Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Contact: Jung Min Bae, MD, PhD    82-31-881-8970 ext 8970    jminbae@gmail.com   
Sponsors and Collaborators
The Catholic University of Korea

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Responsible Party: Jung Min Bae, Department of Dermatology, St. Vincent's Hospital, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03933774    
Other Study ID Numbers: VC18MESI0278
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hyperpigmentation
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents