Human study PLS-00032

Intradermal injections of a hair growth factor formulation for enhancement of human hair regrowth - safety and efficacy evaluation in a first-in-man pilot clinical study.

Uncontrolled pilot study · 1,000 participants enrolled

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • Intradermal injections of a hair growth factor formulation for enhancement of human hair regrowth - safety and efficacy evaluation in a first-in-man pilot clinical study.primary · Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology · 2018-02-26 · PMID 29482481 · DOI

Design and participants

Design
Uncontrolled pilot study
Population
Patients with male- or female-pattern hair loss, including some post-hair-transplant patients.
Conditions
Alopecia (male and female pattern hair loss)
Planned enrollment (registry)
Not reported
Enrolled
1,000
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • Hair growth factor formulation (intervention) · ghk-cu (combination) · Recombinant bioengineered formulation containing VEGF, basic FGF, IGF, KGF, thymosin beta-4 and copper tripeptide-1, in a sterile injectable vehicle · Intradermal injection into scalp skin · Once every 3 weeks for eight sessions; assessments up to 2 months after completion and at 1 year · 1,000 assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Hair fall on hair pull test

unclear outcome · patient-important · Before each of eight sessions · Hair pull test performed before every session

  • Hair growth factor formulation: proportion 83 — Significant reduction in hair fall seen in 83% of patients on hair pull test

Vellus hairs, terminal hairs and shaft diameter

unclear outcome · surrogate · Baseline, fourth session, eighth session, 2 months after completion · Videomicroscopic image evaluation

  • Hair growth factor formulation: narrative — Most patients had fewer vellus hairs, more terminal hairs and increased shaft diameter

Patient-perceived benefit

unclear outcome · patient-important · Not stated · Questionnaire

  • Hair growth factor formulation: proportion 75 — 75% of patients believed the injections were aiding treatment of their hair loss

Total hair count

unclear outcome · surrogate · 1 year · Image-based hair count (method not detailed in abstract)

  • Hair growth factor formulation: change from baseline, p = 0.002 — Statistically significant increase in total hair count continued to be seen at 1 year

Tolerability

unclear outcome · safety · Throughout the study · Physical examination, questionnaires and laboratory examination

  • Hair growth factor formulation: narrative — Treatment was well tolerated

Adverse events

None reported. That is not evidence of safety.

Monitoring: Physical examination, questionnaires and appropriate laboratory examinations were conducted throughout the study. No specific adverse events are reported in the abstract.

The authors concluded (paraphrased): The authors concluded that intradermal injections of this multi-growth-factor hair formulation may be a promising option for treating male and female pattern hair loss.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • no control group: Open-label single-arm design with no placebo or comparator group, so improvement cannot be attributed to treatment.
  • other: Multi-ingredient formulation (growth factors, thymosin beta-4, copper tripeptide-1), so no effect can be attributed to GHK-Cu specifically.
  • inadequate blinding: Open-label study with subjective outcomes such as patient belief in benefit and image evaluation.
  • abstract only: Only the abstract is available, so methods, attrition, numerical results and adverse event details are missing.
  • selective reporting: Results are given mostly as percentages and narrative statements without effect sizes or analyzed numbers.
  • inappropriate population: Hair loss patients receiving scalp injections differ from populations of interest such as aging facial skin.
  • incomplete follow up: Number of patients completing the eight sessions and the 1-year follow-up is not reported.
  • inappropriate endpoint: Main outcomes are hair pull test and videomicroscopy surrogates, plus subjective patient belief, which is unblinded and prone to bias.

Hair fall on hair pull test: Serious concern (Structured limitations appraisal)

For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.

Domain judgments
Control groupSerious concernSingle-arm open-label study, no comparator for hair fall changes.
Selection of participantsNot reportedAbstract does not describe inclusion criteria or recruitment of the 1000 patients.
ConfoundingSerious concernConcurrent treatments and natural fluctuation in hair shedding are not addressed in the abstract.
Follow-up and attritionNot reportedNumber of patients completing sessions and analysed is not reported.
Outcome measurementSerious concernHair pull test assessed unblinded by open-label investigators; a semi-subjective measure.
Completeness of reportingSome concernOnly the proportion with 'significant reduction' is reported, without definition or numerical data.
PrecisionNot reportedNo confidence intervals or denominators are given for the 83% figure.
Funding and conflicts of interestNot reportedFunding and conflicts of interest are not stated in the record.

Uncontrolled open-label design, unblinded semi-subjective measurement and missing details give serious concern.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Vellus hairs, terminal hairs and shaft diameter: Serious concern (Structured limitations appraisal)

For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.

Domain judgments
Control groupSerious concernNo comparator group against which to judge the videomicroscopic changes.
Selection of participantsNot reportedEligibility and recruitment are not described in the abstract.
ConfoundingSerious concernOther hair loss treatments and time effects are not reported as controlled.
Follow-up and attritionNot reportedNumber of patients with images at each timepoint is not reported.
Outcome measurementSome concernVideomicroscopic evaluation; abstract gives no blinding of image assessors.
Completeness of reportingSerious concernReported only as 'most patients' improved, without numbers or statistics.
PrecisionNot reportedNo quantitative estimates or intervals are provided.
Funding and conflicts of interestNot reportedFunding and conflicts of interest are not stated in the record.

Narrative-only reporting without a control group or stated blinding gives serious concern.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Patient-perceived benefit: Serious concern (Structured limitations appraisal)

For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.

Domain judgments
Control groupSerious concernNo placebo group; perceived benefit is highly prone to expectation effects.
Selection of participantsNot reportedRecruitment and eligibility are not described in the abstract.
ConfoundingSerious concernExpectation and concurrent treatments are not accounted for in the open-label design.
Follow-up and attritionNot reportedNumber of questionnaire respondents is not reported.
Outcome measurementSerious concernSelf-reported belief in benefit by unblinded patients is a subjective outcome.
Completeness of reportingSome concernTimepoint and questionnaire instrument are not specified in the abstract.
PrecisionNot reportedNo denominator or interval is given for the 75% figure.
Funding and conflicts of interestNot reportedFunding and conflicts of interest are not stated in the record.

Subjective, unblinded self-report without a control group gives serious concern.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Total hair count: Serious concern (Structured limitations appraisal)

For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.

Domain judgments
Control groupSerious concernIncrease at 1 year is compared only with baseline, with no comparator group.
Selection of participantsNot reportedAbstract does not describe how patients were selected.
ConfoundingSerious concernOther treatments over the year, including post-transplant growth, are not accounted for.
Follow-up and attritionNot reportedNumber of patients assessed at 1 year is not reported.
Outcome measurementSome concernHair count method and assessor blinding are not described in the abstract.
Completeness of reportingSerious concernOnly a p-value is given, with no magnitude of change reported.
PrecisionNot reportedNo effect estimate, confidence interval or analysed number is reported.
Funding and conflicts of interestNot reportedFunding and conflicts of interest are not stated in the record.

Uncontrolled pre-post comparison, unknown attrition and p-value-only reporting give serious concern.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Tolerability: Serious concern (Structured limitations appraisal)

For uncontrolled studies, case series and case reports, where no validated comparative tool applies. It lists limitations; it is not a risk-of-bias rating.

Domain judgments
Control groupSerious concernNo comparator group to contextualise adverse event rates.
Selection of participantsNot reportedEligibility criteria are not described in the abstract.
ConfoundingSome concernAdverse events cannot be attributed to individual ingredients of the combination formulation.
Follow-up and attritionNot reportedNumber of patients completing safety assessments is not reported.
Outcome measurementSome concernSafety assessments were described in general terms; no AE grading is stated.
Completeness of reportingSerious concernSafety is reported only as 'well tolerated', with no adverse event counts.
PrecisionNot reportedNo adverse event frequencies are reported.
Funding and conflicts of interestNot reportedFunding and conflicts of interest are not stated in the record.

A vague narrative safety statement with no counts or comparator gives serious concern.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Peptide Library structured appraisal pl-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Claims this study informs

  • Very low certainty Adverse events, including skin reactions

Where each value comes from

  • adverse_events: PMID 29482481, abstract (sentence 14) · extracted by AI (automated, not verified by a person) · abstract only
  • arms: PMID 29482481, abstract (sentences 5-6) · extracted by AI (automated, not verified by a person) · abstract only
  • author_conclusion: PMID 29482481, abstract (sentence 15) · extracted by AI (automated, not verified by a person) · abstract only
  • design: PMID 29482481, abstract (sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
  • limitations: PMID 29482481, abstract (sentences 4-5) · extracted by AI (automated, not verified by a person) · abstract only
  • outcomes: PMID 29482481, abstract (sentences 7-9) · extracted by AI (automated, not verified by a person) · abstract only
  • participants: PMID 29482481, abstract (sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
  • population: PMID 29482481, abstract (sentences 12 and 15) · extracted by AI (automated, not verified by a person) · abstract only
  • results: PMID 29482481, abstract (sentences 10-14) · extracted by AI (automated, not verified by a person) · abstract only
  • Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).