Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.

Lim HW, Grimes PE, Agbai O, Hamzavi I, Henderson M, Haddican M, Linkner RV, Lebwohl M

JAMA dermatology1 Jan 2015Cited by 114 (Europe PMC)

PMID25230094DOI10.1001/jamadermatol.2014.1875PepBankPUB-25230094

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with generalized vitiligo, afamelanotide implant plus NB-UV-B gave a better response than NB-UV-B alone at day 56.
In plain wordsIn adults with vitiligo, adding afamelanotide to light therapy gave a better response than light therapy alone at day 56.
Peptide
Melanotan I (afamelanotide)
Outcome
IncreaseResponse on Vitiligo Area Scoring Index and VETF scoring at day 56
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Pigmentation · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Source sentences
Summary
Response in the combination therapy group was superior to that in the NB-UV-B monotherapy group (P < .05) at day 56.
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009401
02HumanRandomized controlled trialEfficacy outcome
In adults with vitiligo, afamelanotide plus NB-UV-B led to repigmentation of the face earlier than NB-UV-B alone (41.0 vs 61.0 days).
In plain wordsIn adults with vitiligo, adding afamelanotide led to facial repigmentation sooner than light therapy alone.
Peptide
Melanotan I (afamelanotide)
Outcome
DecreaseTime to repigmentation of the face
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Pigmentation · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Measurements
Time to face repigmentation
41 days
combination therapy
Time to face repigmentation
61 days
NB-UV-B monotherapy
Source sentences
Summary
For the face and upper extremities, a significantly higher percentage of patients in the combination therapy group achieved repigmentation, and at earlier times (face, 41.0 vs 61.0 days [P = .001]; upper extremities, 46.0 vs 69.0 days [P = .003]).
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009402
03HumanRandomized controlled trialEfficacy outcome
In adults with vitiligo, afamelanotide plus NB-UV-B led to repigmentation of the upper extremities earlier than NB-UV-B alone (46.0 vs 69.0 days).
In plain wordsIn adults with vitiligo, adding afamelanotide led to arm repigmentation sooner than light therapy alone.
Peptide
Melanotan I (afamelanotide)
Outcome
DecreaseTime to repigmentation of the upper extremities
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Pigmentation · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Measurements
Time to upper extremity repigmentation
46 days
combination therapy
Time to upper extremity repigmentation
69 days
NB-UV-B monotherapy
Source sentences
Summary
For the face and upper extremities, a significantly higher percentage of patients in the combination therapy group achieved repigmentation, and at earlier times (face, 41.0 vs 61.0 days [P = .001]; upper extremities, 46.0 vs 69.0 days [P = .003]).
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009403
04HumanRandomized controlled trialEfficacy outcome
In adults with vitiligo, repigmentation at day 168 was 48.64% with afamelanotide plus NB-UV-B versus 33.26% with NB-UV-B alone.
In plain wordsIn adults with vitiligo, adding afamelanotide gave more repigmentation at day 168 than light therapy alone.
Peptide
Melanotan I (afamelanotide)
Outcome
IncreaseRepigmentation at day 168
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Pigmentation · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Measurements
Repigmentation
48.64%
combination therapy, day 168
Repigmentation
33.26%
NB-UV-B monotherapy, day 168
Source sentences
Summary
In the combination therapy group, repigmentation was 48.64% (95% CI, 39.49%-57.80%) at day 168 vs 33.26% (95% CI, 24.18%-42.33%) in the NB-UV-B monotherapy group.
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009404
05HumanRandomized controlled trialSafety outcome
Erythema was a notable adverse event in both the combination group and the NB-UV-B monotherapy group.
In plain wordsRedness of the skin occurred in both groups, with and without afamelanotide.
Peptide
Melanotan I (afamelanotide)
Outcome
Direction not reportedErythema
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Adverse events · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Source sentences
Summary
Notable adverse events included erythema in both groups and minor infections and nausea in the combination therapy group.
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009405
06HumanRandomized controlled trialSafety outcome
Minor infections were a notable adverse event in the afamelanotide plus NB-UV-B group.
In plain wordsMinor infections were reported in the group that received afamelanotide with light therapy.
Peptide
Melanotan I (afamelanotide)
Outcome
IncreaseMinor infections
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Adverse events · Infection
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Source sentences
Summary
Notable adverse events included erythema in both groups and minor infections and nausea in the combination therapy group.
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009406
07HumanRandomized controlled trialSafety outcome
Nausea was a notable adverse event in the afamelanotide plus NB-UV-B group.
In plain wordsNausea was reported in the group that received afamelanotide with light therapy.
Peptide
Melanotan I (afamelanotide)
Outcome
IncreaseNausea
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Adverse events · Gastrointestinal
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Source sentences
Summary
Notable adverse events included erythema in both groups and minor infections and nausea in the combination therapy group.
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009407
08HumanRandomized controlled trialEfficacy outcome
In adults with generalized vitiligo, a significantly higher percentage of patients achieved repigmentation of the face and upper extremities with afamelanotide plus NB-UV-B than with NB-UV-B alone.
In plain wordsIn adults with vitiligo, more people given afamelanotide with light therapy had skin color return on the face and arms than with light therapy alone.
Peptide
Melanotan I (afamelanotide)
Outcome
IncreaseProportion of patients with repigmentation of the face and upper extremities
Study
n = 55
Comparator
NB-UV-B monotherapy
Outcome group
Pigmentation · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Source sentences
Summary
For the face and upper extremities, a significantly higher percentage of patients in the combination therapy group achieved repigmentation, and at earlier times (face, 41.0 vs 61.0 days [P = .001]; upper extremities, 46.0 vs 69.0 days [P = .003]).
Report a problemFND-2523009410
09HumanRandomized controlled trialEfficacy outcome
In patients with Fitzpatrick skin phototypes IV to VI, afamelanotide plus NB-UV-B improved the Vitiligo Area Scoring Index at days 56 and 84.
In plain wordsIn people with darker skin types IV to VI, adding afamelanotide improved the vitiligo score at days 56 and 84.
Peptide
Melanotan I (afamelanotide)
Outcome
IncreaseVitiligo Area Scoring Index in SPTs IV to VI at days 56 and 84
Study
n: not reported in source
Comparator
NB-UV-B monotherapy
Outcome group
Pigmentation · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Source sentences
Summary
Comparison between Fitzpatrick SPTs showed patients with SPTs IV to VI in the combination therapy group had improvement in the Vitiligo Area Scoring Index at days 56 and 84 (P < .05)
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009408
10HumanRandomized controlled trialEfficacy outcome
In patients with Fitzpatrick skin phototype III, no significant difference was noted between afamelanotide plus NB-UV-B and NB-UV-B alone.
In plain wordsIn people with skin type III, adding afamelanotide made no significant difference to the vitiligo score.
Peptide
Melanotan I (afamelanotide)
Outcome
No significant changeVitiligo Area Scoring Index in SPT III
Study
n: not reported in source
Comparator
NB-UV-B monotherapy
Outcome group
Pigmentation · Skin and wound
Studied dose
16 mg · subcutaneous · 4 monthsAs given in this study (human).
Source sentences
Summary
no significant difference was noted in patients with SPT III.
3 context sentences(design, population, supporting numbers)
Summary · context
We enrolled men and women 18 years or older with Fitzpatrick skin phototypes (SPTs) III to VI and a confirmed diagnosis of nonsegmental vitiligo that involved 15% to 50% of total body surface area.
Summary · context
Patients were randomized to combination therapy (n = 28) vs NB-UV-B monotherapy (n = 27).
Summary · context
After 1 month of NB-UV-B phototherapy, 16 mg of afamelanotide was administered subcutaneously to the combination therapy group monthly for 4 months while NB-UV-B phototherapy continued; the other group continued to receive NB-UV-B monotherapy.
Report a problemFND-2523009409

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01430195

Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)

Clinuvel Pharmaceuticals Limitedn = 56Jun 2011 to Nov 2012

Vitiligo

Trial page ClinicalTrials.govUpdated 22 Mar 2013

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
13 Oct 2026, 21:44 UTC
Study results updated
Version 1
13 Oct 2026, 16:31 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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