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.
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.
| Control group | Serious concern | Single-arm open-label study, no comparator for hair fall changes. |
|---|---|---|
| Selection of participants | Not reported | Abstract does not describe inclusion criteria or recruitment of the 1000 patients. |
| Confounding | Serious concern | Concurrent treatments and natural fluctuation in hair shedding are not addressed in the abstract. |
| Follow-up and attrition | Not reported | Number of patients completing sessions and analysed is not reported. |
| Outcome measurement | Serious concern | Hair pull test assessed unblinded by open-label investigators; a semi-subjective measure. |
| Completeness of reporting | Some concern | Only the proportion with 'significant reduction' is reported, without definition or numerical data. |
| Precision | Not reported | No confidence intervals or denominators are given for the 83% figure. |
| Funding and conflicts of interest | Not reported | Funding 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.
| Control group | Serious concern | No comparator group against which to judge the videomicroscopic changes. |
|---|---|---|
| Selection of participants | Not reported | Eligibility and recruitment are not described in the abstract. |
| Confounding | Serious concern | Other hair loss treatments and time effects are not reported as controlled. |
| Follow-up and attrition | Not reported | Number of patients with images at each timepoint is not reported. |
| Outcome measurement | Some concern | Videomicroscopic evaluation; abstract gives no blinding of image assessors. |
| Completeness of reporting | Serious concern | Reported only as 'most patients' improved, without numbers or statistics. |
| Precision | Not reported | No quantitative estimates or intervals are provided. |
| Funding and conflicts of interest | Not reported | Funding 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.
| Control group | Serious concern | No placebo group; perceived benefit is highly prone to expectation effects. |
|---|---|---|
| Selection of participants | Not reported | Recruitment and eligibility are not described in the abstract. |
| Confounding | Serious concern | Expectation and concurrent treatments are not accounted for in the open-label design. |
| Follow-up and attrition | Not reported | Number of questionnaire respondents is not reported. |
| Outcome measurement | Serious concern | Self-reported belief in benefit by unblinded patients is a subjective outcome. |
| Completeness of reporting | Some concern | Timepoint and questionnaire instrument are not specified in the abstract. |
| Precision | Not reported | No denominator or interval is given for the 75% figure. |
| Funding and conflicts of interest | Not reported | Funding 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.
| Control group | Serious concern | Increase at 1 year is compared only with baseline, with no comparator group. |
|---|---|---|
| Selection of participants | Not reported | Abstract does not describe how patients were selected. |
| Confounding | Serious concern | Other treatments over the year, including post-transplant growth, are not accounted for. |
| Follow-up and attrition | Not reported | Number of patients assessed at 1 year is not reported. |
| Outcome measurement | Some concern | Hair count method and assessor blinding are not described in the abstract. |
| Completeness of reporting | Serious concern | Only a p-value is given, with no magnitude of change reported. |
| Precision | Not reported | No effect estimate, confidence interval or analysed number is reported. |
| Funding and conflicts of interest | Not reported | Funding 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.
| Control group | Serious concern | No comparator group to contextualise adverse event rates. |
|---|---|---|
| Selection of participants | Not reported | Eligibility criteria are not described in the abstract. |
| Confounding | Some concern | Adverse events cannot be attributed to individual ingredients of the combination formulation. |
| Follow-up and attrition | Not reported | Number of patients completing safety assessments is not reported. |
| Outcome measurement | Some concern | Safety assessments were described in general terms; no AE grading is stated. |
| Completeness of reporting | Serious concern | Safety is reported only as 'well tolerated', with no adverse event counts. |
| Precision | Not reported | No adverse event frequencies are reported. |
| Funding and conflicts of interest | Not reported | Funding 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
- Improves signs of skin aging: not eligible (wrong population) for “Wrinkles and skin quality, measured or rated”
- Is safe for human use: eligible for “Adverse events, including skin reactions”, indirect evidence
- 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).