VitiligoNCT03933774
PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
A study testing Tretinoin 0.05% cream in people with Vitiligo, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Tretinoin 0.05% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2019to 29 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Tretinoin 0.05% cream, Placebo cream
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tretinoin 0.05% creamDrug
Stieva-A Cream 0.05%, 25g, GSK
Placebo creamDrug
Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel
| Study group | Role | What they receive |
|---|---|---|
| Tretinoin 0.05% cream group | Experimental | Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night Receives: Drug: Tretinoin 0.05% cream; Drug: Placebo cream |
| Placebo | Placebo comparator | PHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night Receives: Drug: Tretinoin 0.05% cream; Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Degree of Hyperpigmentation at 12 Weeks
The degree of hyperpigmentation will be assessed as L* value of Lab color space(L stands for lightness, scale from 0 to 100) using spectrophotometer at 12 weeks The higher score means the skin is lighter which means a better outcome.
Measured: at 12 weeks
Secondary outcomes (1)
Number of Participants Who Showed ≥75% Repigmentation
Number of Participants who Showed ≥75% Repigmentation assessed at 12 weeks as % change from baseline degree using VESTA as a reference value.
Measured: change from Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start29 Apr 2019
- Primary completion19 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Min Bae, The Catholic University of Korea
- Investigators
- Jung Min Bae, MD, PhD, Principal investigator, Department of Dermatology, College of Medicine, Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933774
- Sponsor's protocol ID
- VC18MESI0278
- Status last verified
- Aug 2020
- First submitted
- 25 Apr 2019
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ju HJ, Kim SH, Lee JH, Kim GM, Bae JM. Efficacy and safety of tretinoin 0.05% cream to prevent hyperpigmentation during narrowband UV-B phototherapy in patients with facial vitiligo: a randomized clinical trial. J Dermatolog Treat. 2022 May;33(3):1738-1741. doi: 10.1080/09546634.2020.1817298. Epub 2020 Sep 10.
PubMed 32869680
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHNA, Efficacy of Tretinoin Cream on Post-phototherapy Hyperpigmentation
- ClinicalTrials.gov ID
- NCT03933774
- Acronym / sponsor ID
- VC18MESI0278
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tretinoin 0.05% cream group | Experimental | Drug: Tretinoin 0.05% cream, Drug: Placebo creamTretinoin 0.05% cream 25g for 1 month, applied on the half side of the face after randomization, once a day every night |
| Placebo | Placebo comparator | Drug: Tretinoin 0.05% cream, Drug: Placebo creamPHYSIOGEL Daily Moisture Therapy Creme 150ml for 1 month, applied on the other half side of the face once a day every night |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tretinoin 0.05% creamStieva-A Cream 0.05%, 25g, GSK | Drug | Placebo, Tretinoin 0.05% cream group |
| Placebo creamPhysiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel | Drug | Placebo, Tretinoin 0.05% cream group |
Primary outcome
The Degree of Hyperpigmentation at 12 Weeks
Time frame: at 12 weeks
The degree of hyperpigmentation will be assessed as L* value of Lab color space(L stands for lightness, scale from 0 to 100) using spectrophotometer at 12 weeks The higher score means the skin is lighter which means a better outcome.
1 secondary outcome
Number of Participants Who Showed ≥75% Repigmentation
Time frame: change from Baseline and at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32869680Ju HJ, Kim SH, Lee JH, Kim GM, Bae JM. Efficacy and safety of tretinoin 0.05% cream to prevent hyperpigmentation during narrowband UV-B phototherapy in patients with facial vitiligo: a randomized clinical trial. J Dermatolog Treat. 2022 May;33(3):1738-1741. doi: 10.1080/09546634.2020.1817298. Epub 2020 Sep 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Min Bae, MD, PhD principal investigator
Department of Dermatology, College of Medicine, Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tretinoin 0.05% cream in people with Vitiligo, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Degree of Hyperpigmentation at 12 Weeks (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.