Trial · NCT04525157
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
NCT04525157, Phase 2, Completed, Clinuvel Pharmaceuticals Limited; results first posted 2021-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV). Trials, record NCT04525157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04525157
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
- NCT number
- NCT04525157
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Conditions
- Vitiligo
- Interventions
- Afamelanotide, Placebo
- First posted
- 2020-08-25
- Last updated
- 2023-09-22
- Results first posted
- 2021-05-21
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | From Day 0 to Day 196 | A decrease in VASI over time indicates a reduction of the body surface area affected by vitiligo and/ or a reduction in the body sites' degree of depigmentation (possible range 1-100) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | From Day 0 to Day 196 | Change in VASI score from baseline | MEDIAN |
Source ClinicalTrials.gov
Results by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Total Day 28 | 0.00 | Full Range -0.63 to 0.25 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Head and Neck Day 28 | 0.00 | Full Range -0.63 to 0.00 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Hands Day 28 | 0.00 | Full Range 0.00 to 0.00 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Upper Extremities Day 28 | 0.00 | Full Range 0.00 to 0.25 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Trunk Day 28 | 0.00 | Full Range 0.00 to 0.00 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Lower Extremities Day 28 | 0.00 | Full Range 0.00 to 0.00 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Feet Day 28 | 0.00 | Full Range 0.00 to 0.00 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Total Day 56 | -0.05 | Full Range -2.25 to 1.00 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Head and Neck Day 56 | 0.00 | Full Range -0.88 to 1.00 | Change in VASI score from baseline |
| Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI) | Afamelanotide and NB-UVB (Pooled Analysis) | Hands Day 56 | 0.00 | Full Range -0.25 to 0.00 | Change in VASI score from baseline |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Afamelanotide and NB-UVB (Pooled Analysis) | 18 | |
| Overall Study | COMPLETED | Afamelanotide and NB-UVB (Pooled Analysis) | 15 | |
| Overall Study | NOT COMPLETED | Afamelanotide and NB-UVB (Pooled Analysis) | 3 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Afamelanotide and NB-UVB (Pooled Analysis) | 1 | 18 | |
| other | Glomerular filtration rate decreased | Investigations | Afamelanotide and NB-UVB (Pooled Analysis) | 1 | 18 | |
| other | Urinary casts | Investigations | Afamelanotide and NB-UVB (Pooled Analysis) | 1 | 18 | |
| other | Lethargy | Nervous system disorders | Afamelanotide and NB-UVB (Pooled Analysis) | 1 | 18 | |
| other | Nail pigmentation | Skin and subcutaneous tissue disorders | Afamelanotide and NB-UVB (Pooled Analysis) | 2 | 18 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afamelanotide and NB-UVB (Pooled Analysis) | 0 | 18 |
| Total, other adverse events | Afamelanotide and NB-UVB (Pooled Analysis) | 4 | 18 |
| Total, serious adverse events | Afamelanotide and NB-UVB (Pooled Analysis) | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04525157
GET https://conductscience.org/api/trials/v1/NCT04525157/results?page=2